Endoscopic Biliary Drainage in Malignant High Grade Biliary Stricture

Endoscopic Retrograde Cholangiopancreatography Versus Endoscopic Ultrasound Guided Biliary Drainage in Inoperable Malignant Distal Bile Duct Obstruction

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.

Study Overview

• Status: Terminated
• Conditions: Malignant Biliary Stricture
• Intervention / Treatment: Procedure: ERCP with biliary stenting; Procedure: EUS guided biliary drainage

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90230
      • Prince of Songkla University
  • Songkla
    • Hat Yai, Songkla, Thailand, 90110
      • NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ERCP with biliary stenting; Patient will be undergone ERCP with biliary stenting for biliary decompression to relieve biliary obstruction.	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.; Other Names: G1
Active Comparator: EUS guided biliary drainage; Patient will be undergone EGBD for biliary decompression to relieve biliary obstruction.	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.; Other Names: G2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	The number of patients with success of placement of stent in the desired. location	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Prince of Songkla University
• Investigators: Principal Investigator: Nisa Netinatsunton, MD., NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): November 28, 2018
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: ERCP; Endoscopic ultrasound (EUS) guided biliary drainage
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: REC 60-277-21-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The individual data of patients participating in the study are not available for public sharing since the investigators did not obtain the consent to share the data of patient.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No