Comparison Between Transpapillary and Suprapapillary Metal Stent

Comparison Between Transpapillary and Suprapapillary Metal Stent Placement With Endoscopic Sphincterotomy in Common Bile Duct Malignant Obstruction: Prospective Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Common Bile Duct Stricture
• Intervention / Treatment: Procedure: Metal stent placement

Detailed Description

If surgical treatment is not possible in patients with malignant obstruction in the common bile duct, endoscopic metal stent placement to resolve biliary obstruction is a standard treatment that is commonly performed. The metal stents relieve the bile duct stenosis by malignant tumors, helping to drain the bile and improving jaundice. There is no doubt that the center of the metal stent is located in the central part of the biliary stricture, but the location of the lower end of the metal stent is not fixed. The lower end of the metal stent can be located in two main locations, either in the common bile duct above the major ampulla or in the duodenum through the major ampulla. These procedures with supra- or trans-papillary stents are performed in common and are determined by the operator's preference.

According to several retrospective studies so far, trans-papillary metal stents were effective in improving the initial biliary obstruction, but there was no difference in their long-term effects. Mao et al. showed that trans-papillary metal stents increase jaundice-free survival, and Shin et al. revealed the advantages of trans-papillary metal stents because they had a high success rate of secondary endoscopic procedures. On the contrary, Okamoto et al. showed that acute cholangitis more developed after trans-papillary metal stents placement, while Joe et al. revealed the advantages of supra-papillary metal stents because they reduce acute pancreatitis after the procedures. It has not yet been determined which method is effective. So far studies are all retrospective, and some of them placed the metal stents in a percutaneous way rather than endoscopy without sphincterotomy. Besides, some studies included intra-hepatic or hilar bile duct strictures, making it difficult to interpret the results.

Therefore, through a prospective randomized controlled study, the researchers want to compare the clinical results of supra- and trans-papillary metal stents placed by endoscopes in malignant common bile duct obstruction.

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jae Hyuck Chang, Ph, Dr; Phone Number: 82-32-340-7086; Email: wwjjaang@hanmail.net

Study Locations

• Korea, Republic of
  • Kyunggi
    • Bucheon-si, Kyunggi, Korea, Republic of, 14647
      • Recruiting
      • Jae Hyuck Chang
      • Contact: Jae H Chang, PhD; Phone Number: 82323407086; Email: wwjjaang@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with common bile duct obstruction due to malignancy

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: supra-papillary metal stent group; The distal ends of metal stents are located above the major papilla in the common bile duct.	Procedure: Metal stent placement; 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.
Active Comparator: trans-papillary metal stent group; The distal ends of metal stents are located below the major papilla in the duodenum.	Procedure: Metal stent placement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent function maintenance duration	jaundice free survival	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stone or sludge occurrence	in-stent or above stent bile duct stone formation	through study completion, an average of 1 year
in-stent stenosis or tumor overgrowth	stenosis due to tumor growth: in-stent or over the stent	through study completion, an average of 1 year
acute cholangitis occurrence	after procedure acute cholangitis occurrence rate	through study completion, an average of 1 year
stent migration rate	spontaneous migration rate	through study completion, an average of 1 year
overall survival	duration between stent placement and death	From date of randomization until the date of date of death from any cause, assessed up to 36 months

Collaborators and Investigators

• Sponsor: Bucheon St. Mary's Hospital
• Collaborators: Seoul St. Mary's Hospital; St Vincent's Hospital; Incheon St.Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 12, 2023

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: endoscopic retrograde cholangiopancreatography; metal stent; common bile duct obstruction
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: BucheonStMarys

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No