<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03252379</url>
  </required_header>
  <id_info>
    <org_study_id>RF2017</org_study_id>
    <nct_id>NCT03252379</nct_id>
  </id_info>
  <brief_title>Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses</brief_title>
  <official_title>Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Roux-en-Y hepaticojejunostomy is the standard procedure used by most hepatobiliary surgeons&#xD;
      for biliary reconstruction following iatrogenic bile duct injury, benign and malignant CBD&#xD;
      strictures, choledochal cysts and biliary tract tumors management. The incidence of&#xD;
      anastomotic stricture following hepaticojejunostomy in experienced centers ranges between&#xD;
      5%-22%. Hepaticojejunostomy stricture is a serious complication of biliary surgery, if&#xD;
      untreated, can lead to repeated cholangitis, intrahepatic stones formation, biliary&#xD;
      cirrhosis, hepatic failure and eventually death.&#xD;
&#xD;
      Revision of hepaticojejunostomy is a complex procedure, the surgical procedure being made&#xD;
      difficult by the sequelae of long-standing unrelieved biliary obstruction like portal&#xD;
      hypertension due to secondary biliary cirrhosis, atrophy of liver lobes and presence of&#xD;
      cholangiolytic liver abscess.&#xD;
&#xD;
      Endoscopic management is not only the least invasive but also very effective via either&#xD;
      balloon dilatation or stenting of the stricture. In patients with &quot;Roux-en-Y&quot;&#xD;
      hepaticojejunostomy, the endoscopic access to the anastomosis is hampered by the distance&#xD;
      traveled by the jejunal loop until reaching the angle of the enteral anastomosis.&#xD;
&#xD;
      Many modifications of hepaticojejunostomy to provide permanent endoscopic access have been&#xD;
      described in the literature including duodenal, gastric and subcutaneous access loops.&#xD;
&#xD;
      Gastric access loop was first described by Sitaram et al. Ten patients had undergone gastric&#xD;
      access loop. Access loop was entered easily with the gastroscope in five patients in whom it&#xD;
      was attempted. In a series with 16 cases, Hamad MA and El-Amin H assessed different&#xD;
      construction of gastric access loop in the form of bilioenterogastrostomy the overall success&#xD;
      rate of endoscopic access to the HJ through the three types of BEG was 87.5%, while it was&#xD;
      100% for BEG type III, which is a construction similar to the previous series (BEG) type.&#xD;
&#xD;
      Subcutaneous loop access was described by Chen et al. and by Huston et al. In Hutson's series&#xD;
      of 7 patients, recurrent strictures were treated with repeated balloon dilations. The stone&#xD;
      extractions were all successful. In most series, the subcutaneous loop was used for&#xD;
      management os HJ stricture and intrahepatic stones by radiologic intervention. Recently the&#xD;
      subcutaneous loop can be used as an endoscopic biliary access.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective randomized controlled study; which will include all patients who&#xD;
      will undergo Roux-en-Y hepaticojejunostomy reconstruction during the period from 9-2017 to&#xD;
      12-2019.&#xD;
&#xD;
      * Methodology:&#xD;
&#xD;
      Patients will be randomized into three groups according to the surgical procedure performed&#xD;
      as follows:&#xD;
&#xD;
        -  Group A: Patients undergoing modified hepaticojejunostomy with gastric access loop&#xD;
&#xD;
        -  Group B: Patients undergoing modified hepaticojejunostomy with subcutaneous access loop&#xD;
&#xD;
        -  Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop&#xD;
&#xD;
             -  Pre-operative preparation:&#xD;
&#xD;
      For all patients, full medical history, clinical examination, laboratory investigations in&#xD;
      the form of complete blood count (CBC), prothrombin time and concentration (PTT), liver&#xD;
      function tests (LFT) and kidney function tests (KFT) will be performed.&#xD;
&#xD;
      Imaging studies will also be carried out in the form of abdominal ultrasonography (US),&#xD;
      computerized tomography scan (CT) of the abdomen and magnetic resonance cholangiography (MRC)&#xD;
      if indicated.&#xD;
&#xD;
      ERCP will be performed, whenever applicable, whether for diagnosis or therapeutic trial.&#xD;
&#xD;
      * Surgical Technique:&#xD;
&#xD;
      For gastric access loop:&#xD;
&#xD;
        -  Surgical technique: under general intubation anesthesia, a generous right subcostal&#xD;
           incision is performed and could be extended on demand upward to the xiphoid process&#xD;
           and/or to the left subcostal area. Thorough dissection and adhesiolysis is performed to&#xD;
           reach the CBD and prepare the unaffected proximal part for anastomosis. The Roux jejunal&#xD;
           loop is prepared and passed retrocolic to reach the porta hepatis.&#xD;
&#xD;
        -  Then, the hepaticojejunostomy is done via end to side anastomosis using interrupted&#xD;
           sutures of polyglactin of 3-0 or 4-0 size. The anastomosis is done 10-15 cm away from&#xD;
           the free distal end of the Roux jejunum loop to allow anastomosis without tension to the&#xD;
           stomach. A biliary stent may be optionally placed according to operative circumstances&#xD;
           and is brought out through the anterior abdominal wall.&#xD;
&#xD;
        -  The end of the Roux jejunal loop taken up for hepaticojejunostomy is not closed but is&#xD;
           anastomosed to the anterior wall of the gastric antrum near the pyloric orifice.&#xD;
&#xD;
        -  All the enterogastrostomies and enteroenterostomies were in the form of single-layer&#xD;
           continuous sutures of polyglactin of 3-0 size. An intraperitoneal drain was left in the&#xD;
           hepatorenal pouch before closing the incision.&#xD;
&#xD;
      For subcutaneous access loop:&#xD;
&#xD;
      In the subcutaneous access loop, the same steps are done for performing roux-en-Y&#xD;
      hepaticojejunostomy.&#xD;
&#xD;
      The closed free end of roux loop is passed through the anterior abdominal wall in the right&#xD;
      subcostal area and then fixed to the wall in a subcutaneous position using 3/0 polyglactin&#xD;
      sutures. The limb between the hepaticojejunal anastomosis and the subcutaneous fixation&#xD;
      should be short and straight.&#xD;
&#xD;
      Four Ligaclips are used to mark the jejunal loop by clipping the sutures holding the access&#xD;
      loop in place.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients will be randomized into three groups according to the surgical procedure performed as follows:&#xD;
Group A: Patients undergoing modified hepaticojejunostomy with gastric access loop&#xD;
Group B: Patients undergoing modified hepaticojejunostomy with subcutaneous access loop&#xD;
Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>endoscopic access</measure>
    <time_frame>first trial after 2 months (8 weeks) and second trial one year postoperatively</time_frame>
    <description>two trial of endoscopic entry for assessment of hepaticojejunostomy after 2 months (8 weeks) and one year postoperatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mortality rate</measure>
    <time_frame>up to 3 months postoperative for each case</time_frame>
    <description>number of deaths intraoperative and postoperative related to surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bilio-enteric fistula</measure>
    <time_frame>1 month post-operative for each case, data will be available</time_frame>
    <description>anastomotic leak from hepaticojejunostomy or enteroenterostomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hepaticojejunostomy stricture</measure>
    <time_frame>6 months after the last case</time_frame>
    <description>stricture at anastomotic site of hepaticojejunostomy that may occur at any time during the study and detected by development of obstructive jaundice If obstructive jaundice, biliary pain or cholangitis subsequently developed, abdominal ultrasonography followed by MRCP is then carried out. Thereafter, endoscopic assessment of the hepaticojejunostomy was done either by upper endoscopy in Group A or through skin incision and gastroendoscope or choledochoscope in Group B.&#xD;
Patients were reviewed 6 weeks after surgery, at 3-month intervals thereafter for the first year, and at 6-month intervals thereafter, unless they became symptomatic again.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Jaundice, Obstructive</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing modified hepaticojejunostomy with gastric access loop</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B:</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing modified hepaticojejunostomy with subcutaneous access loop</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C:</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>hepaticojejunostomy</intervention_name>
    <description>Under general intubation anesthesia, a generous right subcostal incision is performed and could be extended on demand upward to the xiphoid process and/or to the left subcostal area. Thorough dissection and adhesiolysis is performed to reach the CBD and prepare the unaffected proximal part for anastomosis. The Roux jejunal loop is prepared and passed retrocolic to reach the porta hepatis.&#xD;
Then, the hepaticojejunostomy is done via end to side anastomosis using interrupted sutures of polyglactin of 3-0 or 4-0 size. The anastomosis is done 10-15 cm away from the free distal end of the Roux jejunum loop to allow anastomosis without tension to the stomach. A biliary stent may be optionally placed according to operative circumstances and is brought out through the anterior abdominal wall.</description>
    <arm_group_label>Group C:</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>modified hepaticojejunostomy with subcutaneous access loop</intervention_name>
    <description>In the subcutaneous access loop, the same steps are done for performing roux-en-Y hepaticojejunostomy.&#xD;
The closed free end of roux loop is passed through the anterior abdominal wall in the right subcostal area and then fixed to the wall in a subcutaneous position using 3/0 polyglactin sutures. The limb between the hepaticojejunal anastomosis and the subcutaneous fixation should be short and straight.&#xD;
Four Ligaclips are used to mark the jejunal loop by clipping the sutures holding the access loop in place.</description>
    <arm_group_label>Group B:</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>modified hepaticojejunostomy with gastric access loop</intervention_name>
    <description>In the gastric access loop, the same steps are done for performing roux-en-Y hepaticojejunostomy.The end of the Roux jejunal loop taken up for hepaticojejunostomy is not closed but is anastomosed to the anterior wall of the gastric antrum near the pyloric orifice.&#xD;
All the enterogastrostomies and enteroenterostomies were in the form of single-layer continuous sutures of polyglactin of 3-0 size. An intraperitoneal drain was left in the hepatorenal pouch before closing the incision.</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who will undergo roux-en-Y hepaticojejunostomy reconstruction at General&#xD;
             surgery department - Assiut University.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with malignant disease necessitating roux-en-Y hepaticojejunostomy&#xD;
             (Cholangiocarcinoma or inoperable pancreatic cancer) will be excluded from this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohamad Raafat, MSc</last_name>
    <phone>0201067877622</phone>
    <email>mohamad_raafat10@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt</last_name>
  </overall_contact_backup>
  <reference>
    <citation>Stewart L, Way LW. Bile duct injuries during laparoscopic cholecystectomy. Factors that influence the results of treatment. Arch Surg. 1995 Oct;130(10):1123-8; discussion 1129. doi: 10.1001/archsurg.1995.01430100101019.</citation>
    <PMID>7575127</PMID>
  </reference>
  <reference>
    <citation>Csendes A, Navarrete C, Burdiles P, Yarmuch J. Treatment of common bile duct injuries during laparoscopic cholecystectomy: endoscopic and surgical management. World J Surg. 2001 Oct;25(10):1346-51. doi: 10.1007/s00268-001-0121-5.</citation>
    <PMID>11596901</PMID>
  </reference>
  <reference>
    <citation>Davids PH, Tanka AK, Rauws EA, van Gulik TM, van Leeuwen DJ, de Wit LT, Verbeek PC, Huibregtse K, van der Heyde MN, Tytgat GN. Benign biliary strictures. Surgery or endoscopy? Ann Surg. 1993 Mar;217(3):237-43. doi: 10.1097/00000658-199303000-00004.</citation>
    <PMID>8452402</PMID>
  </reference>
  <reference>
    <citation>Alves A, Farges O, Nicolet J, Watrin T, Sauvanet A, Belghiti J. Incidence and consequence of an hepatic artery injury in patients with postcholecystectomy bile duct strictures. Ann Surg. 2003 Jul;238(1):93-6. doi: 10.1097/01.sla.0000074983.39297.c5.</citation>
    <PMID>12832970</PMID>
  </reference>
  <reference>
    <citation>Moraca RJ, Lee FT, Ryan JA Jr, Traverso LW. Long-term biliary function after reconstruction of major bile duct injuries with hepaticoduodenostomy or hepaticojejunostomy. Arch Surg. 2002 Aug;137(8):889-93; discussion 893-4. doi: 10.1001/archsurg.137.8.889.</citation>
    <PMID>12146986</PMID>
  </reference>
  <reference>
    <citation>Rothlin MA, Lopfe M, Schlumpf R, Largiader F. Long-term results of hepaticojejunostomy for benign lesions of the bile ducts. Am J Surg. 1998 Jan;175(1):22-6. doi: 10.1016/s0002-9610(97)00229-8.</citation>
    <PMID>9445233</PMID>
  </reference>
  <reference>
    <citation>Tocchi A, Costa G, Lepre L, Liotta G, Mazzoni G, Sita A. The long-term outcome of hepaticojejunostomy in the treatment of benign bile duct strictures. Ann Surg. 1996 Aug;224(2):162-7. doi: 10.1097/00000658-199608000-00008.</citation>
    <PMID>8757379</PMID>
  </reference>
  <reference>
    <citation>Lillemoe KD, Melton GB, Cameron JL, Pitt HA, Campbell KA, Talamini MA, Sauter PA, Coleman J, Yeo CJ. Postoperative bile duct strictures: management and outcome in the 1990s. Ann Surg. 2000 Sep;232(3):430-41. doi: 10.1097/00000658-200009000-00015.</citation>
    <PMID>10973393</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamad Raafat</investigator_full_name>
    <investigator_title>Assistant lecturer at General surgery department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Jaundice</mesh_term>
    <mesh_term>Jaundice, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>All patients will be tested for liver functions tests and abdominal ultrasonography at the end of the 2nd post-operative week.&#xD;
All patients of Group A and B will undergo trial of endoscopic assessment after 2 months (8 weeks) and one year postoperatively.&#xD;
If obstructive jaundice, biliary pain or cholangitis subsequently developed, abdominal ultrasonography followed by MRCP is then carried out. Thereafter, endoscopic assessment of the hepaticojejunostomy was done either by upper endoscopy in Group A or through skin incision and gastroendoscope or choledochoscope in Group B.&#xD;
Patients were reviewed 6 weeks after surgery, at 3-month intervals thereafter for the first year, and at 6-month intervals thereafter, unless they became symptomatic again.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03252379
org study id: RF2017
nct id: NCT03252379
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Roux-en-Y hepaticojejunostomy is the standard procedure used by most hepatobiliary surgeons
      for biliary reconstruction following iatrogenic bile duct injury, benign and malignant CBD
      strictures, choledochal cysts and biliary tract tumors management. The incidence of
      anastomotic stricture following hepaticojejunostomy in experienced centers ranges between
      5%-22%. Hepaticojejunostomy stricture is a serious complication of biliary surgery, if
      untreated, can lead to repeated cholangitis, intrahepatic stones formation, biliary
      cirrhosis, hepatic failure and eventually death.

      Revision of hepaticojejunostomy is a complex procedure, the surgical procedure being made
      difficult by the sequelae of long-standing unrelieved biliary obstruction like portal
      hypertension due to secondary biliary cirrhosis, atrophy of liver lobes and presence of
      cholangiolytic liver abscess.

      Endoscopic management is not only the least invasive but also very effective via either
      balloon dilatation or stenting of the stricture. In patients with "Roux-en-Y"
      hepaticojejunostomy, the endoscopic access to the anastomosis is hampered by the distance
      traveled by the jejunal loop until reaching the angle of the enteral anastomosis.

      Many modifications of hepaticojejunostomy to provide permanent endoscopic access have been
      described in the literature including duodenal, gastric and subcutaneous access loops.

      Gastric access loop was first described by Sitaram et al. Ten patients had undergone gastric
      access loop. Access loop was entered easily with the gastroscope in five patients in whom it
      was attempted. In a series with 16 cases, Hamad MA and El-Amin H assessed different
      construction of gastric access loop in the form of bilioenterogastrostomy the overall success
      rate of endoscopic access to the HJ through the three types of BEG was 87.5%, while it was
      100% for BEG type III, which is a construction similar to the previous series (BEG) type.

      Subcutaneous loop access was described by Chen et al. and by Huston et al. In Hutson's series
      of 7 patients, recurrent strictures were treated with repeated balloon dilations. The stone
      extractions were all successful. In most series, the subcutaneous loop was used for
      management os HJ stricture and intrahepatic stones by radiologic intervention. Recently the
      subcutaneous loop can be used as an endoscopic biliary access.
This study is a prospective randomized controlled study; which will include all patients who
      will undergo Roux-en-Y hepaticojejunostomy reconstruction during the period from 9-2017 to
      12-2019.

      * Methodology:

      Patients will be randomized into three groups according to the surgical procedure performed
      as follows:

        -  Group A: Patients undergoing modified hepaticojejunostomy with gastric access loop

        -  Group B: Patients undergoing modified hepaticojejunostomy with subcutaneous access loop

        -  Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop

             -  Pre-operative preparation:

      For all patients, full medical history, clinical examination, laboratory investigations in
      the form of complete blood count (CBC), prothrombin time and concentration (PTT), liver
      function tests (LFT) and kidney function tests (KFT) will be performed.

      Imaging studies will also be carried out in the form of abdominal ultrasonography (US),
      computerized tomography scan (CT) of the abdomen and magnetic resonance cholangiography (MRC)
      if indicated.

      ERCP will be performed, whenever applicable, whether for diagnosis or therapeutic trial.

      * Surgical Technique:

      For gastric access loop:

        -  Surgical technique: under general intubation anesthesia, a generous right subcostal
           incision is performed and could be extended on demand upward to the xiphoid process
           and/or to the left subcostal area. Thorough dissection and adhesiolysis is performed to
           reach the CBD and prepare the unaffected proximal part for anastomosis. The Roux jejunal
           loop is prepared and passed retrocolic to reach the porta hepatis.

        -  Then, the hepaticojejunostomy is done via end to side anastomosis using interrupted
           sutures of polyglactin of 3-0 or 4-0 size. The anastomosis is done 10-15 cm away from
           the free distal end of the Roux jejunum loop to allow anastomosis without tension to the
           stomach. A biliary stent may be optionally placed according to operative circumstances
           and is brought out through the anterior abdominal wall.

        -  The end of the Roux jejunal loop taken up for hepaticojejunostomy is not closed but is
           anastomosed to the anterior wall of the gastric antrum near the pyloric orifice.

        -  All the enterogastrostomies and enteroenterostomies were in the form of single-layer
           continuous sutures of polyglactin of 3-0 size. An intraperitoneal drain was left in the
           hepatorenal pouch before closing the incision.

      For subcutaneous access loop:

      In the subcutaneous access loop, the same steps are done for performing roux-en-Y
      hepaticojejunostomy.

      The closed free end of roux loop is passed through the anterior abdominal wall in the right
      subcostal area and then fixed to the wall in a subcutaneous position using 3/0 polyglactin
      sutures. The limb between the hepaticojejunal anastomosis and the subcutaneous fixation
      should be short and straight.

      Four Ligaclips are used to mark the jejunal loop by clipping the sutures holding the access
      loop in place.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized into three groups according to the surgical procedure performed as follows:
Group A: Patients undergoing modified hepaticojejunostomy with gastric access loop
Group B: Patients undergoing modified hepaticojejunostomy with subcutaneous access loop
Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop
primary purpose: Treatment
masking: Single (Participant)
measure: endoscopic access
time frame: first trial after 2 months (8 weeks) and second trial one year postoperatively
description: two trial of endoscopic entry for assessment of hepaticojejunostomy after 2 months (8 weeks) and one year postoperatively
measure: mortality rate
time frame: up to 3 months postoperative for each case
description: number of deaths intraoperative and postoperative related to surgery
measure: bilio-enteric fistula
time frame: 1 month post-operative for each case, data will be available
description: anastomotic leak from hepaticojejunostomy or enteroenterostomy
measure: hepaticojejunostomy stricture
time frame: 6 months after the last case
description: stricture at anastomotic site of hepaticojejunostomy that may occur at any time during the study and detected by development of obstructive jaundice If obstructive jaundice, biliary pain or cholangitis subsequently developed, abdominal ultrasonography followed by MRCP is then carried out. Thereafter, endoscopic assessment of the hepaticojejunostomy was done either by upper endoscopy in Group A or through skin incision and gastroendoscope or choledochoscope in Group B.
Patients were reviewed 6 weeks after surgery, at 3-month intervals thereafter for the first year, and at 6-month intervals thereafter, unless they became symptomatic again.
arm group label: Group A
arm group type: Experimental
description: Patients undergoing modified hepaticojejunostomy with gastric access loop
arm group label: Group B:
arm group type: Experimental
description: Patients undergoing modified hepaticojejunostomy with subcutaneous access loop
arm group label: Group C:
arm group type: Experimental
description: Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop
intervention type: Procedure
intervention name: hepaticojejunostomy
description: Under general intubation anesthesia, a generous right subcostal incision is performed and could be extended on demand upward to the xiphoid process and/or to the left subcostal area. Thorough dissection and adhesiolysis is performed to reach the CBD and prepare the unaffected proximal part for anastomosis. The Roux jejunal loop is prepared and passed retrocolic to reach the porta hepatis.
Then, the hepaticojejunostomy is done via end to side anastomosis using interrupted sutures of polyglactin of 3-0 or 4-0 size. The anastomosis is done 10-15 cm away from the free distal end of the Roux jejunum loop to allow anastomosis without tension to the stomach. A biliary stent may be optionally placed according to operative circumstances and is brought out through the anterior abdominal wall.
arm group label: Group C:
intervention type: Procedure
intervention name: modified hepaticojejunostomy with subcutaneous access loop
description: In the subcutaneous access loop, the same steps are done for performing roux-en-Y hepaticojejunostomy.
The closed free end of roux loop is passed through the anterior abdominal wall in the right subcostal area and then fixed to the wall in a subcutaneous position using 3/0 polyglactin sutures. The limb between the hepaticojejunal anastomosis and the subcutaneous fixation should be short and straight.
Four Ligaclips are used to mark the jejunal loop by clipping the sutures holding the access loop in place.
arm group label: Group B:
intervention type: Procedure
intervention name: modified hepaticojejunostomy with gastric access loop
description: In the gastric access loop, the same steps are done for performing roux-en-Y hepaticojejunostomy.The end of the Roux jejunal loop taken up for hepaticojejunostomy is not closed but is anastomosed to the anterior wall of the gastric antrum near the pyloric orifice.
All the enterogastrostomies and enteroenterostomies were in the form of single-layer continuous sutures of polyglactin of 3-0 size. An intraperitoneal drain was left in the hepatorenal pouch before closing the incision.
arm group label: Group A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mohamad Raafat, MSc
phone: 0201067877622
email: mohamad_raafat10@yahoo.com
last name: Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt
citation: Stewart L, Way LW. Bile duct injuries during laparoscopic cholecystectomy. Factors that influence the results of treatment. Arch Surg. 1995 Oct;130(10):1123-8; discussion 1129. doi: 10.1001/archsurg.1995.01430100101019.
PMID: 7575127
citation: Csendes A, Navarrete C, Burdiles P, Yarmuch J. Treatment of common bile duct injuries during laparoscopic cholecystectomy: endoscopic and surgical management. World J Surg. 2001 Oct;25(10):1346-51. doi: 10.1007/s00268-001-0121-5.
PMID: 11596901
citation: Davids PH, Tanka AK, Rauws EA, van Gulik TM, van Leeuwen DJ, de Wit LT, Verbeek PC, Huibregtse K, van der Heyde MN, Tytgat GN. Benign biliary strictures. Surgery or endoscopy? Ann Surg. 1993 Mar;217(3):237-43. doi: 10.1097/00000658-199303000-00004.
PMID: 8452402
citation: Alves A, Farges O, Nicolet J, Watrin T, Sauvanet A, Belghiti J. Incidence and consequence of an hepatic artery injury in patients with postcholecystectomy bile duct strictures. Ann Surg. 2003 Jul;238(1):93-6. doi: 10.1097/01.sla.0000074983.39297.c5.
PMID: 12832970
citation: Moraca RJ, Lee FT, Ryan JA Jr, Traverso LW. Long-term biliary function after reconstruction of major bile duct injuries with hepaticoduodenostomy or hepaticojejunostomy. Arch Surg. 2002 Aug;137(8):889-93; discussion 893-4. doi: 10.1001/archsurg.137.8.889.
PMID: 12146986
citation: Rothlin MA, Lopfe M, Schlumpf R, Largiader F. Long-term results of hepaticojejunostomy for benign lesions of the bile ducts. Am J Surg. 1998 Jan;175(1):22-6. doi: 10.1016/s0002-9610(97)00229-8.
PMID: 9445233
citation: Tocchi A, Costa G, Lepre L, Liotta G, Mazzoni G, Sita A. The long-term outcome of hepaticojejunostomy in the treatment of benign bile duct strictures. Ann Surg. 1996 Aug;224(2):162-7. doi: 10.1097/00000658-199608000-00008.
PMID: 8757379
citation: Lillemoe KD, Melton GB, Cameron JL, Pitt HA, Campbell KA, Talamini MA, Sauter PA, Coleman J, Yeo CJ. Postoperative bile duct strictures: management and outcome in the 1990s. Ann Surg. 2000 Sep;232(3):430-41. doi: 10.1097/00000658-200009000-00015.
PMID: 10973393
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamad Raafat
investigator title: Assistant lecturer at General surgery department
mesh term: Jaundice
mesh term: Jaundice, Obstructive
sharing ipd: Undecided
ipd description: All patients will be tested for liver functions tests and abdominal ultrasonography at the end of the 2nd post-operative week.
All patients of Group A and B will undergo trial of endoscopic assessment after 2 months (8 weeks) and one year postoperatively.
If obstructive jaundice, biliary pain or cholangitis subsequently developed, abdominal ultrasonography followed by MRCP is then carried out. Thereafter, endoscopic assessment of the hepaticojejunostomy was done either by upper endoscopy in Group A or through skin incision and gastroendoscope or choledochoscope in Group B.
Patients were reviewed 6 weeks after surgery, at 3-month intervals thereafter for the first year, and at 6-month intervals thereafter, unless they became symptomatic again.