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

NCT04071197 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-08-24

No results posted yet for this study

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

Interventions

DEVICE

Gastostomy-biliary tube

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

External biliary diversion, internal biliary diversion and nasobiliary tube

All biliary diversion modalities other than gastrobiliary tube

Sponsors & Collaborators

  • National Liver Institute, Egypt

    lead OTHER

Principal Investigators

  • Ahmad M Sira, M.D. · Pediatric Hepatology Dep; National Liver Institute, Menoufia University, Egypt

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2020-10-01
Completion
2021-04-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04071197 on ClinicalTrials.gov