Comparison Between Transpapillary and Suprapapillary Metal Stent
Primary Purpose
Common Bile Duct Stricture
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Metal stent placement
Sponsored by
About this trial
This is an interventional treatment trial for Common Bile Duct Stricture focused on measuring metal stent, common bile duct obstruction, endoscopic retrograde cholangiopancreatography
Eligibility Criteria
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
Sites / Locations
- Jae Hyuck ChangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
supra-papillary metal stent group
trans-papillary metal stent group
Arm Description
The distal ends of metal stents are located above the major papilla in the common bile duct.
The distal ends of metal stents are located below the major papilla in the duodenum.
Outcomes
Primary Outcome Measures
Stent function maintenance duration
jaundice free survival
Secondary Outcome Measures
stone or sludge occurrence
in-stent or above stent bile duct stone formation
in-stent stenosis or tumor overgrowth
stenosis due to tumor growth: in-stent or over the stent
acute cholangitis occurrence
after procedure acute cholangitis occurrence rate
stent migration rate
spontaneous migration rate
overall survival
duration between stent placement and death
Full Information
NCT ID
NCT04503291
First Posted
July 30, 2020
Last Updated
July 19, 2022
Sponsor
Bucheon St. Mary's Hospital
Collaborators
Seoul St. Mary's Hospital, Incheon St.Mary's Hospital, St Vincent's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04503291
Brief Title
Comparison Between Transpapillary and Suprapapillary Metal Stent
Official Title
Comparison Between Transpapillary and Suprapapillary Metal Stent Placement With Endoscopic Sphincterotomy in Common Bile Duct Malignant Obstruction: Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bucheon St. Mary's Hospital
Collaborators
Seoul St. Mary's Hospital, Incheon St.Mary's Hospital, St Vincent's Hospital
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Stricture
Keywords
metal stent, common bile duct obstruction, endoscopic retrograde cholangiopancreatography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
supra-papillary metal stent group
trans-papillary metal stent group
Masking
ParticipantOutcomes Assessor
Masking Description
Assigned groups are secreted to the participant and outcome assessors
Allocation
Randomized
Enrollment
156 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
supra-papillary metal stent group
Arm Type
Experimental
Arm Description
The distal ends of metal stents are located above the major papilla in the common bile duct.
Arm Title
trans-papillary metal stent group
Arm Type
Active Comparator
Arm Description
The distal ends of metal stents are located below the major papilla in the duodenum.
Intervention Type
Procedure
Intervention Name(s)
Metal stent placement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stent function maintenance duration
Description
jaundice free survival
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
stone or sludge occurrence
Description
in-stent or above stent bile duct stone formation
Time Frame
through study completion, an average of 1 year
Title
in-stent stenosis or tumor overgrowth
Description
stenosis due to tumor growth: in-stent or over the stent
Time Frame
through study completion, an average of 1 year
Title
acute cholangitis occurrence
Description
after procedure acute cholangitis occurrence rate
Time Frame
through study completion, an average of 1 year
Title
stent migration rate
Description
spontaneous migration rate
Time Frame
through study completion, an average of 1 year
Title
overall survival
Description
duration between stent placement and death
Time Frame
From date of randomization until the date of date of death from any cause, assessed up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Hyuck Chang, Ph, Dr
Phone
82-32-340-7086
Email
wwjjaang@hanmail.net
Facility Information:
Facility Name
Jae Hyuck Chang
City
Bucheon-si
State/Province
Kyunggi
ZIP/Postal Code
14647
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae H Chang, PhD
Phone
82323407086
Email
wwjjaang@hanmail.net
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Comparison Between Transpapillary and Suprapapillary Metal Stent
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