Gastrostomy-Biliary Diversion: Innovative Management for Bile Canalicular Transport Disorders

NCT04071197 | Unknown

• 1 other identifier: GBD-PED-BCTD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Progressive familial intrahepatic cholestasis (PFIC) is a group of disorders that can present early in life with cholestasis and intractable pruritus. Their treatment poses a great challenge, with medical treatment is not successful in many cases. Moreover, the available non-transplant surgeries carry many side effects and different degrees of efficacy. Partial external biliary diversion, internal biliary diversion, and ileal exclusion still lack widespread experience with many side effects. Nasobiliary stent placement has little tolerability, especially in younger age. Gastrobiliary tube is a novel modality for external biliary diversion in such patients.

Conditions

Progressive Familial Intrahepatic Cholestasis

Keywords

bile canalicular transport disorders

Outcome Measures

Primary Outcomes (2)

• Occurrence of bleeding

  number of patients with bleeding

  6 months

• Occurrence of infection

  number of patients with infection

  6 months

Secondary Outcomes (2)

• Serum bilirubin level

  12 months

• Improvement of pruritus

  12 months

Study Arms (2)

Gastrostomy-biliary tube

EXPERIMENTAL

The study group will be subjected to gastrostomy followed by ERCP with nasobiliary stent placement in the CBD with its distal end been exit from the previously performed gastrostomy instead of the nostril

Device: Gastostomy-biliary tube

Other biliary diversion modalities

EXPERIMENTAL

The control group will include those cases with other modalities of therapy as external biliary diversion, internal biliary diversion, and nasobiliary tube

Device: External biliary diversion, internal biliary diversion and nasobiliary tube

Interventions

Gastostomy-biliary tube DEVICE

gastrostomy followed by ERCP with nasobiliary stent placement in the CBD with its distal end been exit from the previously performed gastrostomy instead of the nostril

Gastrostomy-biliary tube

External biliary diversion, internal biliary diversion and nasobiliary tube DEVICE

All biliary diversion modalities other than gastrobiliary tube

Other biliary diversion modalities

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• PFIC cases that are previously responding to medical treatment with recent flare of the disease that doesn't respond to medical therapy
• PFIC cases that are not responding to medical treatment and refusing non-transplant surgery and not indicated for liver transplant
• BRIC cases with frequent attacks not responding to medical therapy and refusing or unable to tolerate nasobiliary stent

You may not qualify if:

• Severe portal hypertensive gastropathy
• Decompensated cirrhosis

Sponsors & Collaborators

• National Liver Institute, Egypt: lead

Study Sites (1)

Pediatric Hepatology, Gastroenterology and Nutrition Department, National Liver Institute, Menoufia University

Shibīn al Kawm, Menofiya, 32511, Egypt

RECRUITING

Related Publications (4)

• van der Woerd WL, van Mil SW, Stapelbroek JM, Klomp LW, van de Graaf SF, Houwen RH. Familial cholestasis: progressive familial intrahepatic cholestasis, benign recurrent intrahepatic cholestasis and intrahepatic cholestasis of pregnancy. Best Pract Res Clin Gastroenterol. 2010 Oct;24(5):541-53. doi: 10.1016/j.bpg.2010.07.010.

  PMID: 20955958 BACKGROUND

• Kaur S, Sharma D, Wadhwa N, Gupta S, Chowdhary SK, Sibal A. Therapeutic interventions in progressive familial intrahepatic cholestasis: experience from a tertiary care centre in north India. Indian J Pediatr. 2012 Feb;79(2):270-3. doi: 10.1007/s12098-011-0516-8. Epub 2011 Jul 19.

  PMID: 21769524 BACKGROUND

• Mochizuki K, Obatake M, Takatsuki M, Nakatomi A, Hayashi T, Okudaira S, Eguchi S. Partial internal biliary diversion for patients with progressive familial intrahepatic cholestasis type 1. Pediatr Surg Int. 2012 Jan;28(1):51-4. doi: 10.1007/s00383-011-3018-x.

  PMID: 22033772 BACKGROUND

• Stapelbroek JM, van Erpecum KJ, Klomp LW, Venneman NG, Schwartz TP, van Berge Henegouwen GP, Devlin J, van Nieuwkerk CM, Knisely AS, Houwen RH. Nasobiliary drainage induces long-lasting remission in benign recurrent intrahepatic cholestasis. Hepatology. 2006 Jan;43(1):51-3. doi: 10.1002/hep.20998.

  PMID: 16374853 BACKGROUND

MeSH Terms

Conditions

Cholestasis, progressive familial intrahepatic 1

Study Officials

• Ahmad M Sira, M.D.

  Pediatric Hepatology Dep; National Liver Institute, Menoufia University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad M Sira, M.D.

CONTACT

+2-048-222-2740; asira@liver.menofia.edu.eg; ahmadsira@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study group will be subjected to gastrostomy followed by ERCP with nasobiliary stent placement in the CBD with its distal end been exit from the previously performed gastrostomy instead of the nostril

Study Record Dates

• First Submitted: August 25, 2019
• First Posted: August 28, 2019
• Study Start: March 10, 2020
• Primary Completion: October 1, 2020
• Study Completion: April 1, 2021
• Last Updated: August 24, 2020

Record last verified: 2020-08

Locations

EG (1)