Comparison Between Transpapillary and Suprapapillary Metal Stent

Common Bile Duct Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04503291
• Other study ID #: BucheonStMarys
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: December 12, 2023

Study information

• Verified date: July 2022
• Source: Bucheon St. Mary's Hospital
• Contact: Jae Hyuck Chang, Ph, Dr
• Phone: 82-32-340-7086
• Email: wwjjaang[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: December 12, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Common Bile Duct Stricture
• Constriction, Pathologic

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Jae Hyuck Chang	Bucheon-si	Kyunggi

Sponsors (4)

Lead Sponsor	Collaborator
Bucheon St. Mary's Hospital	Incheon St.Mary's Hospital, Seoul St. Mary's Hospital, St. Vincent's Hospital-Manhattan

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent function maintenance duration	jaundice free survival	through study completion, an average of 1 year
Secondary	stone or sludge occurrence	in-stent or above stent bile duct stone formation	through study completion, an average of 1 year
Secondary	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
Secondary	acute cholangitis occurrence	after procedure acute cholangitis occurrence rate	through study completion, an average of 1 year
Secondary	stent migration rate	spontaneous migration rate	through study completion, an average of 1 year
Secondary	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