Comparison Between Transpapillary and Suprapapillary Metal Stent

NCT04503291 | Unknown

• 1 other identifier: BucheonStMarys
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

If surgical treatment is not possible in patients with malignant obstruction in the common bile duct, placing metal stents using endoscopy is a standardized treatment to resolve biliary obstruction. The metal stent is located in the bile duct to cover the stenotic portion by malignant tumors. The lower end of the metal stent can be located inside the common bile duct above the major ampulla or in the duodenum through the major ampulla. These two procedures with supra- or trans-papillary stents are currently being performed in general clinical practices, depending on the preference of the endoscopists. Until now, the comparison of the clinical results of the two procedures has been scarcely studied, and there is no prospective study yet. Therefore, researchers aim to compare the clinical results of two stent procedures through prospective randomized controlled studies.

Conditions

Common Bile Duct Stricture

Keywords

metal stent; common bile duct obstruction; endoscopic retrograde cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

• Stent function maintenance duration

  jaundice free survival

  through study completion, an average of 1 year

Secondary Outcomes (5)

• stone or sludge occurrence

  through study completion, an average of 1 year

• in-stent stenosis or tumor overgrowth

  through study completion, an average of 1 year

• acute cholangitis occurrence

  through study completion, an average of 1 year

• stent migration rate

  through study completion, an average of 1 year

• overall survival

  From date of randomization until the date of date of death from any cause, assessed up to 36 months

Study Arms (2)

supra-papillary metal stent group

EXPERIMENTAL

The distal ends of metal stents are located above the major papilla in the common bile duct.

Procedure: Metal stent placement

trans-papillary metal stent group

ACTIVE COMPARATOR

The distal ends of metal stents are located below the major papilla in the duodenum.

Procedure: Metal stent placement

Interventions

Metal stent placement PROCEDURE

Non-covered biliary metal stents are placed by endoscopy. The distal ends of metal stents are located above the major ampulla in the common bile duct or below the major ampulla in the duodenum.

supra-papillary metal stent group; trans-papillary metal stent group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with common bile duct obstruction due to malignancy

You may not qualify if:

• intrahepatic or perihilar bile duct obstruction (except Klatskin type I)
• patients who have operability or want surgery
• strictures located within 2 cm from the end of distal common bile duct
• patients who are not able to undergo endoscopy due to cardiovascular or pulmonary diseases
• patients whose informed consents are not received
• patients in whom an endoscope can not access to the ampulla due to anatomical deformity by previous surgery

Sponsors & Collaborators

• Bucheon St. Mary's Hospital: lead
• Seoul St. Mary's Hospital: collaborator
• Incheon St.Mary's Hospital: collaborator
• St Vincent's Hospital: collaborator

Study Sites (1)

Jae Hyuck Chang

Bucheon-si, Kyunggi, 14647, South Korea

RECRUITING

Central Study Contacts

Jae Hyuck Chang, Ph, Dr

CONTACT

82-32-340-7086; wwjjaang@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Assigned groups are secreted to the participant and outcome assessors
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1. supra-papillary metal stent group 2. trans-papillary metal stent group

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 7, 2020
• Study Start: January 4, 2021
• Primary Completion: October 1, 2023
• Study Completion: December 12, 2023
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date
• Access Criteria: * Investigators whose proposed use of the data has been approved by an independent review committee * To achieve aims in the approved proposal * Proposals may be submitted up to 36 months following article publication.

Locations

KR (1)