Endoscopic Biliary Drainage in Malignant High Grade Biliary Stricture

NCT ID: NCT03530527

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2019-12-15

Brief 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.

Detailed Description

The aim of this study is comparing the efficacy and complications between ERCP and EUS guided biliary drainage in patients with malignant high grade biliary stricture. Malignant high grade biliary stricture has not been well defined. The investigators define this malignant high grade biliary stricture using these arbitrary number include total bilirubin ≥ 15 mg/dl and or bile duct diameter ≥12 mm. based on the investigation's experience.

The study will be divided patients with inoperable malignant high grade biliary stricture into 2 groups, group (A) will be undergone ERCP with biliary stenting and group (B) will be undergone EUS guided biliary drainage. If the assigned intervention is not successful, then patients will be crossed-over to the another intervention.

Conditions

Malignant Biliary Stricture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ERCP with biliary stenting

Patient will be undergone ERCP with biliary stenting for biliary decompression to relieve biliary obstruction.

Group Type: ACTIVE_COMPARATOR

ERCP with biliary stenting

Intervention Type: PROCEDURE

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.

EUS guided biliary drainage

Patient will be undergone EGBD for biliary decompression to relieve biliary obstruction.

Group Type: ACTIVE_COMPARATOR

EUS guided biliary drainage

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

G1; G2

Eligibility Criteria

Inclusion Criteria

1. distant metastasis

2. major vascular involvement (unreconstructible Superior mesenteric vein/Portal vein, superior mesenteric artery, common hepatic artery and celiac artery)

3. metastasis to lymphnode beyond the field or surgery IV) Jaundice, total bilirubin ≥15 mg/dl and/ or Common bile duct diameter ≥12 mm

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prince of Songkla University

OTHER

Sponsor Role: lead

Responsible Party

Nisa Netinatsunton

Secretory of NKC Institute of Gastroenterology and Hepatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nisa Netinatsunton, MD.

Role: PRINCIPAL_INVESTIGATOR

NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.

Locations

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Countries

Thailand

Other Identifiers

REC 60-277-21-1

Identifier Type: -

Identifier Source: org_study_id