<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/NCT03252509</url>
  </required_header>
  <id_info>
    <org_study_id>INCA RI</org_study_id>
    <nct_id>NCT03252509</nct_id>
  </id_info>
  <brief_title>Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors</brief_title>
  <official_title>Outpatient Percutaneous Radiologic Gastrostomy in Patients With Head and Neck Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Cancer, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Nacional de Cancer, Brazil</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>
      This study intends to evaluate the security and success rate of large bore percutaneous&#xD;
      radiologic gastrostomy in patients with head and neck tumors, as a outpatient procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Percutaneous gastrostomy is a procedure that intends to provide prolonged alimentary access&#xD;
      to patients with normal gastrointestinal tract, which are unable to eat or are facing&#xD;
      troubles with deglutition.&#xD;
&#xD;
      Nowadays it is considered as the first line procedure to prolonged enteral access on this&#xD;
      patients.&#xD;
&#xD;
      The indications to perform a percutaneous gastrostomy in a cancer center are usually related&#xD;
      to head and neck, central nervous system and esophagus tumors. In our institution around 80%&#xD;
      of the percutaneous gastrostomy are performed in patients with head an neck tumors.&#xD;
&#xD;
      Although percutaneous gastrostomy is considered a safe procedure, there are some&#xD;
      complications related, specially in oncologic patients. Those complications are reported in&#xD;
      about 40% of the cases.&#xD;
&#xD;
      Percutaneous gastrostomy is usually performed as a inpatient procedure, which leads to&#xD;
      hospitalization costs. However, some studies have shown that is safe and viable to perform&#xD;
      percutaneous gastrostomy (both endoscopic or radiologic), as a outpatient procedure, in&#xD;
      patients with head a neck tumors.&#xD;
&#xD;
      As both techniques (endoscopic and radiologic) present similar results, patients treated in&#xD;
      our institution that require a percutaneous gastrostomy are referred to endoscopic and&#xD;
      interventional radiology departments.&#xD;
&#xD;
      Some of these patients are selected to undergo an outpatient procedure, based on social and&#xD;
      clinical criteria.&#xD;
&#xD;
      The majority of the available data shows that both the endoscopic and the radiologic&#xD;
      techniques present similar results in terms of security and rate of precocious and late&#xD;
      complications, and that both are superior than the surgical technique, considering they are&#xD;
      least invasive and related with lower rates of complication and costs.&#xD;
&#xD;
      In the present, the traction (Gauderer-Ponsky) technique is the most widely used in our&#xD;
      institution for the endoscopic procedure.&#xD;
&#xD;
      In the interventional radiology department the percutaneous gastrostomy is performed using&#xD;
      the introduction (Russel) technique, in which a guidewire is positioned after the stomach&#xD;
      needle puncture, made under ultrasound or fluoroscopic guidance. After that, the tract is&#xD;
      progressively dilated to allow the introduction of the gastrostomy balloon catheter, through&#xD;
      the abdominal wall, using a peel-away sheath.&#xD;
&#xD;
      This same technique can be performed for the endoscopic gastrostomy, using the same&#xD;
      gastrostomy kit, but under endoscopic guidance.&#xD;
&#xD;
      Some authors suggest that the introduction technique, although more challenging, is&#xD;
      associated with less stoma infections, because is the only one that is not associated with&#xD;
      oral catheterization.&#xD;
&#xD;
      For the patients with head an neck tumors, there is also a reduced risk of metastases&#xD;
      implants on the puncture site.&#xD;
&#xD;
      Besides those considerations, the data available is still not consensual.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Actual">November 21, 2018</completion_date>
  <primary_completion_date type="Actual">November 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pre a post interventional study, in patients with head and neck neoplasms, eligible for an outpatient procedure.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complication rate.</measure>
    <time_frame>Up to 24 weeks.</time_frame>
    <description>Rate of other complications like bleeding, infection, cutaneous fistulae.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of gastrostomy.</measure>
    <time_frame>Up to 24 weeks.</time_frame>
    <description>Duration of primary gastrostomy tube.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success rate.</measure>
    <time_frame>Immediately.</time_frame>
    <description>Gastrostomy tube insertion into gastric lumen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure duration time.</measure>
    <time_frame>Immediately after the procedure.</time_frame>
    <description>Time necessary to place the gastrostomy tube, from gastric distention to local dressing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity.</measure>
    <time_frame>Immediately after the procedure and during the total follow-up period - Up to 24 weeks.</time_frame>
    <description>Pain will be measured according to pain score (1-10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional procedures.</measure>
    <time_frame>Up to 24 weeks.</time_frame>
    <description>Procedures required after gastrostomy placement, like tube reinsertion or tube changes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Gastrostomy outcomes after the follow-up period.</measure>
    <time_frame>Up to 24 weeks.</time_frame>
    <description>Death for any reason using the gastrostomy tube, elective withdrawal after recovery of swallow function and persistence with gastrostomy tube.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Gastrostomy</condition>
  <condition>Head and Neck Neoplasms</condition>
  <condition>Malignant Neoplasm</condition>
  <arm_group>
    <arm_group_label>Percutaneous radiologic gastrostomy.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Outpatient percutaneous radiologic gastrostomy in patients with head and neck tumors before, during or after the oncologic treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous radiologic gastrostomy</intervention_name>
    <description>Percutaneous radiologic gastrostomy: Under conscious sedation and local analgesia, the ultrasound is performed to determine abdominal structures. The stomach is distended using room air through a nasogastric catheter or a 5 French (Fr) catheter. Gastropexy is performed under fluoroscopic guidance. The stomach is accessed using a 18 gauge (G) needle. Guidewire is advanced to the stomach. Progressive tract dilatations until the size of the gastrostomy tube is achieved. The catheter is advanced through the peel-away sheath. The catheter's balloon is inflated with 10ml of distilled water. Iodine contrast is injected to confirm position. After the procedure, the patient is observed for 3 hours. If there are no complications, the patient is discharged.</description>
    <arm_group_label>Percutaneous radiologic gastrostomy.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgical risk ASA I-III, Karnofsky Performance Status &gt;70, acceptance and&#xD;
             comprehension of the orientations and after-care, adequate social a familiar support,&#xD;
             easy access to the hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who live more than one hour away from the hospital, coagulopathies, refuse to&#xD;
             join the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hugo R Gouveia</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional do Câncer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional do Cancer - HC1</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20.231-092</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Campoli PM, Cardoso DM, Turchi MD, Ejima FH, Mota OM. Assessment of safety and feasibility of a new technical variant of gastropexy for percutaneous endoscopic gastrostomy: an experience with 435 cases. BMC Gastroenterol. 2009 Jun 26;9:48. doi: 10.1186/1471-230X-9-48.</citation>
    <PMID>19558672</PMID>
  </reference>
  <reference>
    <citation>Cantwell CP, Perumpillichira JJ, Maher MM, Hahn PF, Arellano R, Gervais DA, Mueller PR. Antibiotic prophylaxis for percutaneous radiologic gastrostomy and gastrojejunostomy insertion in outpatients with head and neck cancer. J Vasc Interv Radiol. 2008 Apr;19(4):571-5. doi: 10.1016/j.jvir.2007.11.012.</citation>
    <PMID>18375303</PMID>
  </reference>
  <reference>
    <citation>Cosentini EP, Sautner T, Gnant M, Winkelbauer F, Teleky B, Jakesz R. Outcomes of surgical, percutaneous endoscopic, and percutaneous radiologic gastrostomies. Arch Surg. 1998 Oct;133(10):1076-83. doi: 10.1001/archsurg.133.10.1076.</citation>
    <PMID>9790204</PMID>
  </reference>
  <reference>
    <citation>Foster JM, Filocamo P, Nava H, Schiff M, Hicks W, Rigual N, Smith J, Loree T, Gibbs JF. The introducer technique is the optimal method for placing percutaneous endoscopic gastrostomy tubes in head and neck cancer patients. Surg Endosc. 2007 Jun;21(6):897-901. doi: 10.1007/s00464-006-9068-9. Epub 2006 Dec 16.</citation>
    <PMID>17180272</PMID>
  </reference>
  <reference>
    <citation>Gauderer MW, Ponsky JL, Izant RJ Jr. Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg. 1980 Dec;15(6):872-5. doi: 10.1016/s0022-3468(80)80296-x.</citation>
    <PMID>6780678</PMID>
  </reference>
  <reference>
    <citation>Giordano-Nappi JH, Ishioka S, Maluf-Filho F, Hondo FY, Matuguma SE, Sakai P. A new device for the introducer technique for percutaneous endoscopic gastrostomy placement. Endoscopy. 2007 Feb;39 Suppl 1:E274-5. doi: 10.1055/s-2007-966615. Epub 2007 Oct 24. No abstract available.</citation>
    <PMID>17957639</PMID>
  </reference>
  <reference>
    <citation>Hiki N, Maetani I, Suzuki Y, Washizawa N, Fukuda T, Yamaguchi T; Tokyo Standard PEG Study Group. Reduced risk of peristomal infection of direct percutaneous endoscopic gastrostomy in cancer patients: comparison with the pull percutaneous endoscopic gastrostomy procedure. J Am Coll Surg. 2008 Nov;207(5):737-44. doi: 10.1016/j.jamcollsurg.2008.06.335. Epub 2008 Aug 9.</citation>
    <PMID>18954787</PMID>
  </reference>
  <reference>
    <citation>Horiuchi A, Nakayama Y, Tanaka N, Fujii H, Kajiyama M. Prospective randomized trial comparing the direct method using a 24 Fr bumper-button-type device with the pull method for percutaneous endoscopic gastrostomy. Endoscopy. 2008 Sep;40(9):722-6. doi: 10.1055/s-2008-1077490. Epub 2008 Sep 4.</citation>
    <PMID>18773341</PMID>
  </reference>
  <reference>
    <citation>Koide T, Inamori M, Kusakabe A, Uchiyama T, Watanabe S, Iida H, Endo H, Hosono K, Sakamoto Y, Fujita K, Takahashi H, Yoneda M, Tokoro C, Yasuzaki H, Goto A, Abe Y, Kobayashi N, Kubota K, Saito S, Nahajima A. Early complications following percutaneous endoscopic gastrostomy: results of use of a new direct technique. Hepatogastroenterology. 2010 Nov-Dec;57(104):1639-44.</citation>
    <PMID>21443135</PMID>
  </reference>
  <reference>
    <citation>Kusaka K, Itoh T, Kawaura K, Yamakawa J, Takahashi T, Kanda T. Three-point fixation of stomach to abdominal wall in the percutaneous endoscopic gastrostomy procedure. Endoscopy. 2005 May;37(5):494. doi: 10.1055/s-2005-861233. No abstract available.</citation>
    <PMID>15844032</PMID>
  </reference>
  <reference>
    <citation>Maetani I, Tada T, Ukita T, Inoue H, Sakai Y, Yoshikawa M. PEG with introducer or pull method: a prospective randomized comparison. Gastrointest Endosc. 2003 Jun;57(7):837-41. doi: 10.1016/s0016-5107(03)70017-0.</citation>
    <PMID>12776029</PMID>
  </reference>
  <reference>
    <citation>de Souza e Mello GF, Lukashok HP, Meine GC, Small IA, de Carvalho RL, Guimaraes DP, Mansur GR. Outpatient percutaneous endoscopic gastrostomy in selected head and neck cancer patients. Surg Endosc. 2009 Jul;23(7):1487-93. doi: 10.1007/s00464-009-0381-y. Epub 2009 Mar 5.</citation>
    <PMID>19263126</PMID>
  </reference>
  <reference>
    <citation>Russell TR, Brotman M, Norris F. Percutaneous gastrostomy. A new simplified and cost-effective technique. Am J Surg. 1984 Jul;148(1):132-7. doi: 10.1016/0002-9610(84)90300-3.</citation>
    <PMID>6430111</PMID>
  </reference>
  <reference>
    <citation>Rustom IK, Jebreel A, Tayyab M, England RJ, Stafford ND. Percutaneous endoscopic, radiological and surgical gastrostomy tubes: a comparison study in head and neck cancer patients. J Laryngol Otol. 2006 Jun;120(6):463-6. doi: 10.1017/S0022215106000661.</citation>
    <PMID>16772054</PMID>
  </reference>
  <reference>
    <citation>Sacks BA, Vine HS, Palestrant AM, Ellison HP, Shropshire D, Lowe R. A nonoperative technique for establishment of a gastrostomy in the dog. Invest Radiol. 1983 Sep-Oct;18(5):485-7. doi: 10.1097/00004424-198309000-00015.</citation>
    <PMID>6642944</PMID>
  </reference>
  <reference>
    <citation>Tucker AT, Gourin CG, Ghegan MD, Porubsky ES, Martindale RG, Terris DJ. 'Push' versus 'pull' percutaneous endoscopic gastrostomy tube placement in patients with advanced head and neck cancer. Laryngoscope. 2003 Nov;113(11):1898-902. doi: 10.1097/00005537-200311000-00007.</citation>
    <PMID>14603043</PMID>
  </reference>
  <reference>
    <citation>Van Dyck E, Macken EJ, Roth B, Pelckmans PA, Moreels TG. Safety of pull-type and introducer percutaneous endoscopic gastrostomy tubes in oncology patients: a retrospective analysis. BMC Gastroenterol. 2011 Mar 16;11:23. doi: 10.1186/1471-230X-11-23.</citation>
    <PMID>21410958</PMID>
  </reference>
  <reference>
    <citation>Walton GM. Complications of percutaneous gastrostomy in patients with head and neck cancer--an analysis of 42 consecutive patients. Ann R Coll Surg Engl. 1999 Jul;81(4):272-6.</citation>
    <PMID>10615198</PMID>
  </reference>
  <reference>
    <citation>Wilhelm SM, Ortega KA, Stellato TA. Guidelines for identification and management of outpatient percutaneous endoscopic gastrostomy tube placement. Am J Surg. 2010 Mar;199(3):396-9; discussion 399-400. doi: 10.1016/j.amjsurg.2009.08.023.</citation>
    <PMID>20226918</PMID>
  </reference>
  <reference>
    <citation>Wollman B, D'Agostino HB. Percutaneous radiologic and endoscopic gastrostomy: a 3-year institutional analysis of procedure performance. AJR Am J Roentgenol. 1997 Dec;169(6):1551-3. doi: 10.2214/ajr.169.6.9393163.</citation>
    <PMID>9393163</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 15, 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>April 12, 2021</last_update_submitted>
  <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>percutaneous radiologic gastrostomy</keyword>
  <keyword>Head and Neck Neoplasms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03252509
org study id: INCA RI
nct id: NCT03252509
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study intends to evaluate the security and success rate of large bore percutaneous
      radiologic gastrostomy in patients with head and neck tumors, as a outpatient procedure.
Percutaneous gastrostomy is a procedure that intends to provide prolonged alimentary access
      to patients with normal gastrointestinal tract, which are unable to eat or are facing
      troubles with deglutition.

      Nowadays it is considered as the first line procedure to prolonged enteral access on this
      patients.

      The indications to perform a percutaneous gastrostomy in a cancer center are usually related
      to head and neck, central nervous system and esophagus tumors. In our institution around 80%
      of the percutaneous gastrostomy are performed in patients with head an neck tumors.

      Although percutaneous gastrostomy is considered a safe procedure, there are some
      complications related, specially in oncologic patients. Those complications are reported in
      about 40% of the cases.

      Percutaneous gastrostomy is usually performed as a inpatient procedure, which leads to
      hospitalization costs. However, some studies have shown that is safe and viable to perform
      percutaneous gastrostomy (both endoscopic or radiologic), as a outpatient procedure, in
      patients with head a neck tumors.

      As both techniques (endoscopic and radiologic) present similar results, patients treated in
      our institution that require a percutaneous gastrostomy are referred to endoscopic and
      interventional radiology departments.

      Some of these patients are selected to undergo an outpatient procedure, based on social and
      clinical criteria.

      The majority of the available data shows that both the endoscopic and the radiologic
      techniques present similar results in terms of security and rate of precocious and late
      complications, and that both are superior than the surgical technique, considering they are
      least invasive and related with lower rates of complication and costs.

      In the present, the traction (Gauderer-Ponsky) technique is the most widely used in our
      institution for the endoscopic procedure.

      In the interventional radiology department the percutaneous gastrostomy is performed using
      the introduction (Russel) technique, in which a guidewire is positioned after the stomach
      needle puncture, made under ultrasound or fluoroscopic guidance. After that, the tract is
      progressively dilated to allow the introduction of the gastrostomy balloon catheter, through
      the abdominal wall, using a peel-away sheath.

      This same technique can be performed for the endoscopic gastrostomy, using the same
      gastrostomy kit, but under endoscopic guidance.

      Some authors suggest that the introduction technique, although more challenging, is
      associated with less stoma infections, because is the only one that is not associated with
      oral catheterization.

      For the patients with head an neck tumors, there is also a reduced risk of metastases
      implants on the puncture site.

      Besides those considerations, the data available is still not consensual.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pre a post interventional study, in patients with head and neck neoplasms, eligible for an outpatient procedure.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Complication rate.
time frame: Up to 24 weeks.
description: Rate of other complications like bleeding, infection, cutaneous fistulae.
measure: Duration of gastrostomy.
time frame: Up to 24 weeks.
description: Duration of primary gastrostomy tube.
measure: Technical success rate.
time frame: Immediately.
description: Gastrostomy tube insertion into gastric lumen.
measure: Procedure duration time.
time frame: Immediately after the procedure.
description: Time necessary to place the gastrostomy tube, from gastric distention to local dressing.
measure: Pain intensity.
time frame: Immediately after the procedure and during the total follow-up period - Up to 24 weeks.
description: Pain will be measured according to pain score (1-10).
measure: Additional procedures.
time frame: Up to 24 weeks.
description: Procedures required after gastrostomy placement, like tube reinsertion or tube changes.
measure: Gastrostomy outcomes after the follow-up period.
time frame: Up to 24 weeks.
description: Death for any reason using the gastrostomy tube, elective withdrawal after recovery of swallow function and persistence with gastrostomy tube.
arm group label: Percutaneous radiologic gastrostomy.
arm group type: Experimental
description: Outpatient percutaneous radiologic gastrostomy in patients with head and neck tumors before, during or after the oncologic treatment.
intervention type: Procedure
intervention name: Percutaneous radiologic gastrostomy
description: Percutaneous radiologic gastrostomy: Under conscious sedation and local analgesia, the ultrasound is performed to determine abdominal structures. The stomach is distended using room air through a nasogastric catheter or a 5 French (Fr) catheter. Gastropexy is performed under fluoroscopic guidance. The stomach is accessed using a 18 gauge (G) needle. Guidewire is advanced to the stomach. Progressive tract dilatations until the size of the gastrostomy tube is achieved. The catheter is advanced through the peel-away sheath. The catheter's balloon is inflated with 10ml of distilled water. Iodine contrast is injected to confirm position. After the procedure, the patient is observed for 3 hours. If there are no complications, the patient is discharged.
arm group label: Percutaneous radiologic gastrostomy.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hugo R Gouveia
role: Principal Investigator
affiliation: Instituto Nacional do Câncer
facility: 
country: Brazil
citation: Campoli PM, Cardoso DM, Turchi MD, Ejima FH, Mota OM. Assessment of safety and feasibility of a new technical variant of gastropexy for percutaneous endoscopic gastrostomy: an experience with 435 cases. BMC Gastroenterol. 2009 Jun 26;9:48. doi: 10.1186/1471-230X-9-48.
PMID: 19558672
citation: Cantwell CP, Perumpillichira JJ, Maher MM, Hahn PF, Arellano R, Gervais DA, Mueller PR. Antibiotic prophylaxis for percutaneous radiologic gastrostomy and gastrojejunostomy insertion in outpatients with head and neck cancer. J Vasc Interv Radiol. 2008 Apr;19(4):571-5. doi: 10.1016/j.jvir.2007.11.012.
PMID: 18375303
citation: Cosentini EP, Sautner T, Gnant M, Winkelbauer F, Teleky B, Jakesz R. Outcomes of surgical, percutaneous endoscopic, and percutaneous radiologic gastrostomies. Arch Surg. 1998 Oct;133(10):1076-83. doi: 10.1001/archsurg.133.10.1076.
PMID: 9790204
citation: Foster JM, Filocamo P, Nava H, Schiff M, Hicks W, Rigual N, Smith J, Loree T, Gibbs JF. The introducer technique is the optimal method for placing percutaneous endoscopic gastrostomy tubes in head and neck cancer patients. Surg Endosc. 2007 Jun;21(6):897-901. doi: 10.1007/s00464-006-9068-9. Epub 2006 Dec 16.
PMID: 17180272
citation: Gauderer MW, Ponsky JL, Izant RJ Jr. Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg. 1980 Dec;15(6):872-5. doi: 10.1016/s0022-3468(80)80296-x.
PMID: 6780678
citation: Giordano-Nappi JH, Ishioka S, Maluf-Filho F, Hondo FY, Matuguma SE, Sakai P. A new device for the introducer technique for percutaneous endoscopic gastrostomy placement. Endoscopy. 2007 Feb;39 Suppl 1:E274-5. doi: 10.1055/s-2007-966615. Epub 2007 Oct 24. No abstract available.
PMID: 17957639
citation: Hiki N, Maetani I, Suzuki Y, Washizawa N, Fukuda T, Yamaguchi T; Tokyo Standard PEG Study Group. Reduced risk of peristomal infection of direct percutaneous endoscopic gastrostomy in cancer patients: comparison with the pull percutaneous endoscopic gastrostomy procedure. J Am Coll Surg. 2008 Nov;207(5):737-44. doi: 10.1016/j.jamcollsurg.2008.06.335. Epub 2008 Aug 9.
PMID: 18954787
citation: Horiuchi A, Nakayama Y, Tanaka N, Fujii H, Kajiyama M. Prospective randomized trial comparing the direct method using a 24 Fr bumper-button-type device with the pull method for percutaneous endoscopic gastrostomy. Endoscopy. 2008 Sep;40(9):722-6. doi: 10.1055/s-2008-1077490. Epub 2008 Sep 4.
PMID: 18773341
citation: Koide T, Inamori M, Kusakabe A, Uchiyama T, Watanabe S, Iida H, Endo H, Hosono K, Sakamoto Y, Fujita K, Takahashi H, Yoneda M, Tokoro C, Yasuzaki H, Goto A, Abe Y, Kobayashi N, Kubota K, Saito S, Nahajima A. Early complications following percutaneous endoscopic gastrostomy: results of use of a new direct technique. Hepatogastroenterology. 2010 Nov-Dec;57(104):1639-44.
PMID: 21443135
citation: Kusaka K, Itoh T, Kawaura K, Yamakawa J, Takahashi T, Kanda T. Three-point fixation of stomach to abdominal wall in the percutaneous endoscopic gastrostomy procedure. Endoscopy. 2005 May;37(5):494. doi: 10.1055/s-2005-861233. No abstract available.
PMID: 15844032
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responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Head and Neck Neoplasms
sharing ipd: No