Back to resultsEndoscopic Biliary Drainage in Malignant High Grade Biliary Stricture
Primary Purpose
Malignant Biliary Stricture
Status
Terminated
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
ERCP with biliary stenting
EUS guided biliary drainage
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Biliary Stricture focused on measuring ERCP, Endoscopic ultrasound (EUS) guided biliary drainage
Eligibility Criteria
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
- 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
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.
Sites / Locations
- Prince of Songkla University
- NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ERCP with biliary stenting
EUS guided biliary drainage
Arm Description
Patient will be undergone ERCP with biliary stenting for biliary decompression to relieve biliary obstruction.
Patient will be undergone EGBD for biliary decompression to relieve biliary obstruction.
Outcomes
Primary Outcome Measures
Technical success rate
The number of patients with success of placement of stent in the desired. location
Secondary Outcome Measures
Clinical success rates
The number of patients with total bilirubin drop more than 30 % compare with baseline after successful biliary stent placement.
Total procedure time
The time interval between the intubation of the scope until the placement of the stent
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.
The mortality rates
The number of patients with death related to the procedure.
Stent patency
The time interval between biliary stent insertion and the need for unscheduled re-interventions.
Full Information
NCT ID
NCT03530527
First Posted
May 8, 2018
Last Updated
March 26, 2021
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT03530527
Brief Title
Endoscopic Biliary Drainage in Malignant High Grade Biliary Stricture
Official Title
Endoscopic Retrograde Cholangiopancreatography Versus Endoscopic Ultrasound Guided Biliary Drainage in Inoperable Malignant Distal Bile Duct Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated because of difficulty in completing the study as originally planned
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
December 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Biliary Stricture
Keywords
ERCP, Endoscopic ultrasound (EUS) guided biliary drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ERCP with biliary stenting
Arm Type
Active Comparator
Arm Description
Patient will be undergone ERCP with biliary stenting for biliary decompression to relieve biliary obstruction.
Arm Title
EUS guided biliary drainage
Arm Type
Active Comparator
Arm Description
Patient will be undergone EGBD for biliary decompression to relieve biliary obstruction.
Intervention Type
Procedure
Intervention Name(s)
ERCP with biliary stenting
Other Intervention Name(s)
G1
Intervention Description
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
Intervention Name(s)
EUS guided biliary drainage
Other Intervention Name(s)
G2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Technical success rate
Description
The number of patients with success of placement of stent in the desired. location
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Clinical success rates
Description
The number of patients with total bilirubin drop more than 30 % compare with baseline after successful biliary stent placement.
Time Frame
2 weeks
Title
Total procedure time
Description
The time interval between the intubation of the scope until the placement of the stent
Time Frame
24 hours
Title
The complication rates
Description
The number of patients who developed complications related procedure included pancreatitis, bleeding, perforation, cholangitis as defined and graded according to the consensus guideline.
Time Frame
4 weeks
Title
The mortality rates
Description
The number of patients with death related to the procedure.
Time Frame
1 weeks
Title
Stent patency
Description
The time interval between biliary stent insertion and the need for unscheduled re-interventions.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nisa Netinatsunton, MD.
Organizational Affiliation
NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90230
Country
Thailand
Facility Name
NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
City
Hat Yai
State/Province
Songkla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Endoscopic Biliary Drainage in Malignant High Grade Biliary Stricture
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