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Endoscopic Biliary Drainage in Malignant High Grade Biliary Stricture

NCT03530527 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-04-01

No results posted yet for this study

Summary

Biliary drainage is the mainstay of the palliative treatment in patients with inoperable malignant bile duct stricture. Endoscopic retrograde cholangiopancreatography (ERCP) is the cornerstone of biliary drainage method in these patients. However, ERCP is sometime unsuccessful to perform because of the presence of the high grade biliary stricture, tumor invasion of duodenum and ampulla of vater and surgically altered gastrointestinal anatomy. Endoscopic ultrasound (EUS) guided biliary drainage has been emerged as an alternative procedure to traditional surgical bypass and percutaneous trans hepatic biliary drainage after failed ERCP. There were few data to directly compare between ERCP and EUS guided biliary drainage and in patients with malignant high grade biliary stricture.

Conditions

  • Malignant Biliary Stricture

Interventions

PROCEDURE

ERCP with biliary stenting

ERCP with biliary stent is performed using a side view duodenoscope of Olympus (TJF-160). Biliary cannulation is performed using a sphincterotome and 0.035 inch jag wire, and cholangiogarm is done to assess common bile duct diameter, and length of biliary stricture. Biliary sphincterotomy is then performed. A straight biliary stent is placed across stricture bile duct.

PROCEDURE

EUS guided biliary drainage

EUS guided biliary drainage is performed using a linear echoendoscope of Olympus (GFUCT240). Extrahepatic bile duct was identified from duodenal bulb, then 19 G needle is inserted into bile duct with confirmed with cholangiogram. The fistula tract is dilated using a 6 Fr cystotome (Wilson Cook Medical). A double pigtail stent is placed across biliary-enteric fistula.

Sponsors & Collaborators

  • Prince of Songkla University

    lead OTHER

Principal Investigators

  • Nisa Netinatsunton, MD. · NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2018-11-28
Completion
2019-12-15

Countries

  • Thailand

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 NCT03530527 on ClinicalTrials.gov