<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/NCT04494763</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-PHT-BA01</org_study_id>
    <nct_id>NCT04494763</nct_id>
  </id_info>
  <brief_title>Primary Prophylaxis for Variceal Bleed in Biliary Atresia</brief_title>
  <acronym>BA-BB</acronym>
  <official_title>Propanolol for Primary Prophylaxis for Variceal Bleed in Biliary Atresia - An Open Label Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Biliary atresia is the commonest etiology of neonatal cholestasis and is the most common&#xD;
      indication for pediatric liver transplantation world-wide. Kasai-portoenterostomy (KPE) is&#xD;
      the operative procedure of choice which helps in restoration of biliary flow and preventing&#xD;
      rapid progression of fibrosis. Only 50-60% of infants have a successful surgery in terms of&#xD;
      normalization of bilirubin (&lt;2 mg/dL) after 3 months. Remaining 40-50% have rapid progression&#xD;
      of PHT and eventual decompensation. Additionally, around 50-70% of infants with successful&#xD;
      KPE have 1 or more episodes of cholangitis, and the severe ones if left untreated lead to&#xD;
      progressive portal hypertension. Moreover in Indian setting a significant number of infants&#xD;
      with biliary atresia reach late when the KPE is not feasible, and this group develops very&#xD;
      rapid PHT and decompensation. Hence, overall around 70-80% of infants and children develop&#xD;
      PHT within 5 years of age. Variceal bleed has been shown to be an important determinant of&#xD;
      survival in infants with high bilirubin. Usage of beta-blockers in adult cirrhotics has been&#xD;
      shown to reduce the progression of varices and incidence of variceal bleed. Although many&#xD;
      pediatric hepatology centers worldwide use beta-blockers, there has been no controlled trial&#xD;
      specifically to address this issue in children with biliary atresia. So, we planned this&#xD;
      study to evaluate the efficacy of beta-blockers as primary prophylaxis for prevention of&#xD;
      variceal bleed in biliary atresia children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      (a) Aim and Objectives:&#xD;
&#xD;
      Aim: To study the effect of beta-blockers for primary prophylaxis of variceal bleed in&#xD;
      infants and children with biliary atresia.&#xD;
&#xD;
      Primary objective: Bleeding free survival over 18 months FU&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
      (i) Progression, persistence or regression of esophageal and gastric varices, and portal&#xD;
      hypertensive gastropathy over 3, 6, 12 and 18 months FU&#xD;
&#xD;
      (ii) Overall survival at 18 months FU&#xD;
&#xD;
      (b) Methodology: This will be an open label randomized controlled study where infants and&#xD;
      children with biliary atresia from 6 months to 5 years fulfilling inclusion and exclusion&#xD;
      criteria will be enrolled to receive propanolol or placebo for a duration of 18 months or&#xD;
      till the occurrence of variceal bleed.&#xD;
&#xD;
      i. Study design: Open label randomized controlled study with stratified randomization.&#xD;
&#xD;
      ii. Intervention: Beta-blocker (Propanolol) versus placebo.&#xD;
&#xD;
      iii. Study period: 1.5 years&#xD;
&#xD;
      iv. Study population: Infants and children from 6 months to 5 years of age with Biliary&#xD;
      atresia fulfilling the inclusion and exclusion criteria.&#xD;
&#xD;
      (c) Expected outcome of the project: Beta-blockers reduce the incidence of variceal bleed in&#xD;
      infants and children with biliary atresia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Anticipated">June 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 13, 2022</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>Open label Randomized controlled trial - Block randomization</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bleeding free survival over 18 months follow-up</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression, persistence or regression of esophageal varices</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression, persistence or regression of gastric varices</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression, persistence or regression of portal hypertensive gastropathy</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression, persistence or regression of esophageal varices</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression, persistence or regression of gastric varices</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression, persistence or regression of portal hypertensive gastropathy</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression, persistence or regression of esophageal varices</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression, persistence or regression of gastric varices</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression, persistence or regression of portal hypertensive gastropathy</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression, persistence or regression of esophageal varices</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression, persistence or regression of gastric varices</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression, persistence or regression of portal hypertensive gastropathy</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">92</enrollment>
  <condition>Portal Hypertension, Biliary Atresia</condition>
  <arm_group>
    <arm_group_label>Propanolol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose: 1 to 8 mg/kg/day in 1 to 2 divided doses adjusted to achieve target reduction in resting heart rate by 25% from baseline Frequency: once to Twice daily Route of Administration: Oral Duration: 18 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo in a similar manner</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propanolol</intervention_name>
    <description>Non-selective Beta-blocker</description>
    <arm_group_label>Propanolol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Inactive drug</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Infants and children with biliary atresia from 6 months to 5 years of&#xD;
        age fulfilling either of the following conditions:&#xD;
&#xD;
        i. With unsuccessful Kasai portoenterostomy procedure with a bilirubin &gt;2 mg/dL, or ii. Who&#xD;
        did not underwent Kasai portoenterostomy, or iii. With successful Kasai portoenterostomy&#xD;
        procedure with a bilirubin &lt;2 mg/dL, but with features of portal hypertension i.e. clinical&#xD;
        splenomegaly and/or thrombocytopenia (platelets &lt; 1,00,000/mm3).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i. History suggestive of hyper-reactive airway disease. ii. Congestive heart failure iii.&#xD;
        Any degree of heart block (I,, II, III) iv. Infants and children already on beta-blockers&#xD;
        in last 4 weeks. v. Portal vein atresia or thrombosis. vi. History of variceal bleed. vii.&#xD;
        Infants and children on prophylactic or therapeutic endotherapy (band ligation or&#xD;
        sclerotherapy).&#xD;
&#xD;
        viii. Potential liver transplant within 1 month.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rajeev Khanna, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor, Pediatric Hepatology, Institute of Liver and Biliary Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rajeev Khanna, MD</last_name>
    <phone>+919654246963</phone>
    <email>drrajeev_khanna@rediffmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of Liver and Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rajeev Khanna, MD</last_name>
      <phone>+919654246963</phone>
      <email>drrajeev_khanna@rediffmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ankit Bhardwaj, MD</last_name>
      <phone>+9146300000</phone>
      <email>bhardwaj.ankit3@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Duche M, Ducot B, Ackermann O, Guerin F, Jacquemin E, Bernard O. Portal hypertension in children: High-risk varices, primary prophylaxis and consequences of bleeding. J Hepatol. 2017 Feb;66(2):320-327. doi: 10.1016/j.jhep.2016.09.006. Epub 2016 Sep 20.</citation>
    <PMID>27663417</PMID>
  </reference>
  <reference>
    <citation>Fagundes ED, Ferreira AR, Roquete ML, Penna FJ, Goulart EM, Figueiredo Filho PP, Bittencourt PF, Carvalho SD, Albuquerque W. Clinical and laboratory predictors of esophageal varices in children and adolescents with portal hypertension syndrome. J Pediatr Gastroenterol Nutr. 2008 Feb;46(2):178-83. doi: 10.1097/MPG.0b013e318156ff07.</citation>
    <PMID>18223377</PMID>
  </reference>
  <reference>
    <citation>Poddar U, Thapa BR, Rao KL, Singh K. Etiological spectrum of esophageal varices due to portal hypertension in Indian children: is it different from the West? J Gastroenterol Hepatol. 2008 Sep;23(9):1354-7. doi: 10.1111/j.1440-1746.2007.05102.x. Epub 2007 Aug 6.</citation>
    <PMID>17683492</PMID>
  </reference>
  <reference>
    <citation>Zargar SA, Javid G, Khan BA, Yattoo GN, Shah AH, Gulzar GM, Singh J, Rehman BU, Din Z. Endoscopic ligation compared with sclerotherapy for bleeding esophageal varices in children with extrahepatic portal venous obstruction. Hepatology. 2002 Sep;36(3):666-72. doi: 10.1053/jhep.2002.35278.</citation>
    <PMID>12198659</PMID>
  </reference>
  <reference>
    <citation>Zargar SA, Yattoo GN, Javid G, Khan BA, Shah AH, Shah NA, Gulzar GM, Singh J, Shafi HM. Fifteen-year follow up of endoscopic injection sclerotherapy in children with extrahepatic portal venous obstruction. J Gastroenterol Hepatol. 2004 Feb;19(2):139-45. doi: 10.1111/j.1440-1746.2004.03224.x.</citation>
    <PMID>14731122</PMID>
  </reference>
  <reference>
    <citation>Duche M, Ducot B, Tournay E, Fabre M, Cohen J, Jacquemin E, Bernard O. Prognostic value of endoscopy in children with biliary atresia at risk for early development of varices and bleeding. Gastroenterology. 2010 Dec;139(6):1952-60. doi: 10.1053/j.gastro.2010.07.004. Epub 2010 Jul 14.</citation>
    <PMID>20637201</PMID>
  </reference>
  <reference>
    <citation>Duche M, Ducot B, Ackermann O, Baujard C, Chevret L, Frank-Soltysiak M, Jacquemin E, Bernard O. Experience with endoscopic management of high-risk gastroesophageal varices, with and without bleeding, in children with biliary atresia. Gastroenterology. 2013 Oct;145(4):801-7. doi: 10.1053/j.gastro.2013.06.022. Epub 2013 Jun 19.</citation>
    <PMID>23792202</PMID>
  </reference>
  <reference>
    <citation>Shashidhar H, Langhans N, Grand RJ. Propranolol in prevention of portal hypertensive hemorrhage in children: a pilot study. J Pediatr Gastroenterol Nutr. 1999 Jul;29(1):12-7. doi: 10.1097/00005176-199907000-00007.</citation>
    <PMID>10400097</PMID>
  </reference>
  <reference>
    <citation>Drolet BA, Frommelt PC, Chamlin SL, Haggstrom A, Bauman NM, Chiu YE, Chun RH, Garzon MC, Holland KE, Liberman L, MacLellan-Tobert S, Mancini AJ, Metry D, Puttgen KB, Seefeldt M, Sidbury R, Ward KM, Blei F, Baselga E, Cassidy L, Darrow DH, Joachim S, Kwon EK, Martin K, Perkins J, Siegel DH, Boucek RJ, Frieden IJ. Initiation and use of propranolol for infantile hemangioma: report of a consensus conference. Pediatrics. 2013 Jan;131(1):128-40. doi: 10.1542/peds.2012-1691. Epub 2012 Dec 24.</citation>
    <PMID>23266923</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 19, 2018</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>March 17, 2021</last_update_submitted>
  <last_update_submitted_qc>March 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Variceal bleed</keyword>
  <keyword>primary prophylaxis</keyword>
  <keyword>Biliary atresia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Portal</mesh_term>
    <mesh_term>Biliary Atresia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propranolol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Endoscopic details of the patients on propanolol or placebo</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/NCT04494763
org study id: ILBS-PHT-BA01
nct id: NCT04494763
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Biliary atresia is the commonest etiology of neonatal cholestasis and is the most common
      indication for pediatric liver transplantation world-wide. Kasai-portoenterostomy (KPE) is
      the operative procedure of choice which helps in restoration of biliary flow and preventing
      rapid progression of fibrosis. Only 50-60% of infants have a successful surgery in terms of
      normalization of bilirubin (<2 mg/dL) after 3 months. Remaining 40-50% have rapid progression
      of PHT and eventual decompensation. Additionally, around 50-70% of infants with successful
      KPE have 1 or more episodes of cholangitis, and the severe ones if left untreated lead to
      progressive portal hypertension. Moreover in Indian setting a significant number of infants
      with biliary atresia reach late when the KPE is not feasible, and this group develops very
      rapid PHT and decompensation. Hence, overall around 70-80% of infants and children develop
      PHT within 5 years of age. Variceal bleed has been shown to be an important determinant of
      survival in infants with high bilirubin. Usage of beta-blockers in adult cirrhotics has been
      shown to reduce the progression of varices and incidence of variceal bleed. Although many
      pediatric hepatology centers worldwide use beta-blockers, there has been no controlled trial
      specifically to address this issue in children with biliary atresia. So, we planned this
      study to evaluate the efficacy of beta-blockers as primary prophylaxis for prevention of
      variceal bleed in biliary atresia children.
(a) Aim and Objectives:

      Aim: To study the effect of beta-blockers for primary prophylaxis of variceal bleed in
      infants and children with biliary atresia.

      Primary objective: Bleeding free survival over 18 months FU

      Secondary objectives:

      (i) Progression, persistence or regression of esophageal and gastric varices, and portal
      hypertensive gastropathy over 3, 6, 12 and 18 months FU

      (ii) Overall survival at 18 months FU

      (b) Methodology: This will be an open label randomized controlled study where infants and
      children with biliary atresia from 6 months to 5 years fulfilling inclusion and exclusion
      criteria will be enrolled to receive propanolol or placebo for a duration of 18 months or
      till the occurrence of variceal bleed.

      i. Study design: Open label randomized controlled study with stratified randomization.

      ii. Intervention: Beta-blocker (Propanolol) versus placebo.

      iii. Study period: 1.5 years

      iv. Study population: Infants and children from 6 months to 5 years of age with Biliary
      atresia fulfilling the inclusion and exclusion criteria.

      (c) Expected outcome of the project: Beta-blockers reduce the incidence of variceal bleed in
      infants and children with biliary atresia.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Open label Randomized controlled trial - Block randomization
primary purpose: Prevention
masking: None (Open Label)
measure: Bleeding free survival over 18 months follow-up
time frame: 18 months
measure: Progression, persistence or regression of esophageal varices
time frame: 3 months
measure: Progression, persistence or regression of gastric varices
time frame: 3 months
measure: Progression, persistence or regression of portal hypertensive gastropathy
time frame: 3 months
measure: Progression, persistence or regression of esophageal varices
time frame: 6 months
measure: Progression, persistence or regression of gastric varices
time frame: 6 months
measure: Progression, persistence or regression of portal hypertensive gastropathy
time frame: 6 months
measure: Progression, persistence or regression of esophageal varices
time frame: 12 months
measure: Progression, persistence or regression of gastric varices
time frame: 12 months
measure: Progression, persistence or regression of portal hypertensive gastropathy
time frame: 12 months
measure: Progression, persistence or regression of esophageal varices
time frame: 18 months
measure: Progression, persistence or regression of gastric varices
time frame: 18 months
measure: Progression, persistence or regression of portal hypertensive gastropathy
time frame: 18 months
measure: Overall survival
time frame: 6 months
measure: Overall survival
time frame: 12 months
measure: Overall survival
time frame: 18 months
arm group label: Propanolol
arm group type: Experimental
description: Dose: 1 to 8 mg/kg/day in 1 to 2 divided doses adjusted to achieve target reduction in resting heart rate by 25% from baseline Frequency: once to Twice daily Route of Administration: Oral Duration: 18 months
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo in a similar manner
intervention type: Drug
intervention name: Propanolol
description: Non-selective Beta-blocker
arm group label: Propanolol
intervention type: Other
intervention name: Placebo
description: Inactive drug
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Months
maximum age: 5 Years
healthy volunteers: No
last name: Rajeev Khanna, MD
role: Principal Investigator
affiliation: Associate Professor, Pediatric Hepatology, Institute of Liver and Biliary Sciences
last name: Rajeev Khanna, MD
phone: +919654246963
email: drrajeev_khanna@rediffmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: India
citation: Duche M, Ducot B, Ackermann O, Guerin F, Jacquemin E, Bernard O. Portal hypertension in children: High-risk varices, primary prophylaxis and consequences of bleeding. J Hepatol. 2017 Feb;66(2):320-327. doi: 10.1016/j.jhep.2016.09.006. Epub 2016 Sep 20.
PMID: 27663417
citation: Fagundes ED, Ferreira AR, Roquete ML, Penna FJ, Goulart EM, Figueiredo Filho PP, Bittencourt PF, Carvalho SD, Albuquerque W. Clinical and laboratory predictors of esophageal varices in children and adolescents with portal hypertension syndrome. J Pediatr Gastroenterol Nutr. 2008 Feb;46(2):178-83. doi: 10.1097/MPG.0b013e318156ff07.
PMID: 18223377
citation: Poddar U, Thapa BR, Rao KL, Singh K. Etiological spectrum of esophageal varices due to portal hypertension in Indian children: is it different from the West? J Gastroenterol Hepatol. 2008 Sep;23(9):1354-7. doi: 10.1111/j.1440-1746.2007.05102.x. Epub 2007 Aug 6.
PMID: 17683492
citation: Zargar SA, Javid G, Khan BA, Yattoo GN, Shah AH, Gulzar GM, Singh J, Rehman BU, Din Z. Endoscopic ligation compared with sclerotherapy for bleeding esophageal varices in children with extrahepatic portal venous obstruction. Hepatology. 2002 Sep;36(3):666-72. doi: 10.1053/jhep.2002.35278.
PMID: 12198659
citation: Zargar SA, Yattoo GN, Javid G, Khan BA, Shah AH, Shah NA, Gulzar GM, Singh J, Shafi HM. Fifteen-year follow up of endoscopic injection sclerotherapy in children with extrahepatic portal venous obstruction. J Gastroenterol Hepatol. 2004 Feb;19(2):139-45. doi: 10.1111/j.1440-1746.2004.03224.x.
PMID: 14731122
citation: Duche M, Ducot B, Tournay E, Fabre M, Cohen J, Jacquemin E, Bernard O. Prognostic value of endoscopy in children with biliary atresia at risk for early development of varices and bleeding. Gastroenterology. 2010 Dec;139(6):1952-60. doi: 10.1053/j.gastro.2010.07.004. Epub 2010 Jul 14.
PMID: 20637201
citation: Duche M, Ducot B, Ackermann O, Baujard C, Chevret L, Frank-Soltysiak M, Jacquemin E, Bernard O. Experience with endoscopic management of high-risk gastroesophageal varices, with and without bleeding, in children with biliary atresia. Gastroenterology. 2013 Oct;145(4):801-7. doi: 10.1053/j.gastro.2013.06.022. Epub 2013 Jun 19.
PMID: 23792202
citation: Shashidhar H, Langhans N, Grand RJ. Propranolol in prevention of portal hypertensive hemorrhage in children: a pilot study. J Pediatr Gastroenterol Nutr. 1999 Jul;29(1):12-7. doi: 10.1097/00005176-199907000-00007.
PMID: 10400097
citation: Drolet BA, Frommelt PC, Chamlin SL, Haggstrom A, Bauman NM, Chiu YE, Chun RH, Garzon MC, Holland KE, Liberman L, MacLellan-Tobert S, Mancini AJ, Metry D, Puttgen KB, Seefeldt M, Sidbury R, Ward KM, Blei F, Baselga E, Cassidy L, Darrow DH, Joachim S, Kwon EK, Martin K, Perkins J, Siegel DH, Boucek RJ, Frieden IJ. Initiation and use of propranolol for infantile hemangioma: report of a consensus conference. Pediatrics. 2013 Jan;131(1):128-40. doi: 10.1542/peds.2012-1691. Epub 2012 Dec 24.
PMID: 23266923
responsible party type: Sponsor
mesh term: Hypertension, Portal
mesh term: Biliary Atresia
mesh term: Propranolol
sharing ipd: Undecided
ipd description: Endoscopic details of the patients on propanolol or placebo