Endoscopic Biliary Drainage in Malignant High Grade Biliary Stricture

Not Applicable

Terminated

• Conditions: Malignant Biliary Stricture
• Interventions: Procedure: ERCP with biliary stenting; Procedure: EUS guided biliary drainage

• Registration Number: NCT03530527
• Lead Sponsor: Prince of Songkla University

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.

Study Timeline

• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-21
• Study Start: 2018-08-20
• Primary Completion: 2018-11-28
• Study Completion: 2019-12-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

I) Patients aged > 18 years. II) Clinical, laboratory data, imaging and or histology suggestive of malignant distal bile duct strictures that occurs as a result of pancreatic adenocarcinoma, cholangiocarcinoma, ampullary carcinoma, duodenal carcinoma, gallbladder cancer and metastasis malignant bile duct obstruction III) Inoperability by tumor staging, medically unfit or patient wishes

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

Exclusion Criteria

I) pregnancy II) uncorrectable coagulopathy ( international normalized ratio ≥ 1.5 ) III) thrombocytopenia (platelet count < 50,000 ) IV) extremely poor general condition, ERCP with stent insertion impossible for ethical reasons V) an extension of stricture to the main biliary confluent (hilum) or the existence of obstructive duodenal invasion VI) active suppurative cholangitis VI) surgically altered anatomy (i.e. Billroth II or Roux-en-Y reconstruction ) VII ) previous treatment with bile duct stent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERCP with biliary stenting	ERCP with biliary stenting	Patient will be undergone ERCP with biliary stenting for biliary decompression to relieve biliary obstruction.
EUS guided biliary drainage	EUS guided biliary drainage	Patient will be undergone EGBD for biliary decompression to relieve biliary obstruction.

Primary Outcome Measures

Name	Time	Method
Technical success rate	24 hours	The number of patients with success of placement of stent in the desired. location

Secondary Outcome Measures

Name	Time	Method
Clinical success rates	2 weeks	The number of patients with total bilirubin drop more than 30 % compare with baseline after successful biliary stent placement.
Total procedure time	24 hours	The time interval between the intubation of the scope until the placement of the stent
The complication rates	4 weeks	The number of patients who developed complications related procedure included pancreatitis, bleeding, perforation, cholangitis as defined and graded according to the consensus guideline.
The mortality rates	1 weeks	The number of patients with death related to the procedure.
Stent patency	12 weeks	The time interval between biliary stent insertion and the need for unscheduled re-interventions.

Trial Locations

Locations (2)

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University; 🇹🇭 Hat Yai, Songkla, Thailand

Prince of Songkla University; 🇹🇭 Hat Yai, Songkhla, Thailand