Comparison Between Transpapillary and Suprapapillary Metal Stent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2023-12-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Common Bile Duct Stricture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. supra-papillary metal stent group
2. trans-papillary metal stent group

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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Study Groups

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supra-papillary metal stent group

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

Group Type EXPERIMENTAL

Metal stent placement

Intervention Type 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.

trans-papillary metal stent group

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

Group Type ACTIVE_COMPARATOR

Metal stent placement

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No