Endoscopic Biliary Drainage in Malignant High Grade Biliary Stricture

NCT03530527 | Terminated

• 1 other identifier: REC 60-277-21-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Biliary Stricture

Keywords

ERCP; Endoscopic ultrasound (EUS) guided biliary drainage

Outcome Measures

Primary Outcomes (1)

• Technical success rate

  The number of patients with success of placement of stent in the desired. location

  24 hours

Secondary Outcomes (5)

• Clinical success rates

  2 weeks

• Total procedure time

  24 hours

• The complication rates

  4 weeks

• The mortality rates

  1 weeks

• Stent patency

  12 weeks

Study Arms (2)

ERCP with biliary stenting

ACTIVE COMPARATOR

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

Procedure: ERCP with biliary stenting

EUS guided biliary drainage

ACTIVE COMPARATOR

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

Procedure: EUS guided biliary drainage

Interventions

ERCP with biliary stenting 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.

Also known as: G1

ERCP with biliary stenting

EUS guided biliary drainage 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.

Also known as: G2

EUS guided biliary drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• distant metastasis
• major vascular involvement (unreconstructible Superior mesenteric vein/Portal vein, superior mesenteric artery, common hepatic artery and celiac artery)
• metastasis to lymphnode beyond the field or surgery IV) Jaundice, total bilirubin ≥15 mg/dl and/ or Common bile duct diameter ≥12 mm

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (2)

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90230, Thailand

Location

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Nisa Netinatsunton, MD.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Secretory of NKC Institute of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 21, 2018
• Study Start: August 20, 2018
• Primary Completion: November 28, 2018
• Study Completion: December 15, 2019
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)