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Comparison Between Transpapillary and Suprapapillary Metal Stent

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ClinicalTrials.gov Identifier: NCT04503291
Recruitment Status : Not yet recruiting
First Posted : August 7, 2020
Last Update Posted : August 7, 2020
Sponsor:
Collaborators:
Seoul St. Mary's Hospital
Incheon St.Mary's Hospital
St. Vincent's Hospital-Manhattan
Information provided by (Responsible Party):
Jae Hyuck Chang, Bucheon St. Mary's Hospital

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.


Condition or disease Intervention/treatment Phase
Common Bile Duct Stricture Procedure: Metal stent placement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. supra-papillary metal stent group
  2. trans-papillary metal stent group
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Assigned groups are secreted to the participant and outcome assessors
Primary Purpose: Treatment
Official Title: Comparison Between Transpapillary and Suprapapillary Metal Stent Placement With Endoscopic Sphincterotomy in Common Bile Duct Malignant Obstruction: Prospective Randomized Controlled Study
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : December 12, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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.




Primary Outcome Measures :
  1. Stent function maintenance duration [ Time Frame: through study completion, an average of 1 year ]
    jaundice free survival


Secondary Outcome Measures :
  1. stone or sludge occurrence [ Time Frame: through study completion, an average of 1 year ]
    in-stent or above stent bile duct stone formation

  2. in-stent stenosis or tumor overgrowth [ Time Frame: through study completion, an average of 1 year ]
    stenosis due to tumor growth: in-stent or over the stent

  3. acute cholangitis occurrence [ Time Frame: through study completion, an average of 1 year ]
    after procedure acute cholangitis occurrence rate

  4. stent migration rate [ Time Frame: through study completion, an average of 1 year ]
    spontaneous migration rate

  5. overall survival [ Time Frame: From date of randomization until the date of date of death from any cause, assessed up to 36 months ]
    duration between stent placement and death



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503291


Contacts
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Contact: Jae Hyuck Chang, Ph, Dr 82-32-340-7086 wwjjaang@hanmail.net

Sponsors and Collaborators
Bucheon St. Mary's Hospital
Seoul St. Mary's Hospital
Incheon St.Mary's Hospital
St. Vincent's Hospital-Manhattan
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Responsible Party: Jae Hyuck Chang, Professor, Bucheon St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT04503291    
Other Study ID Numbers: BucheonStMarys
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jae Hyuck Chang, Bucheon St. Mary's Hospital:
metal stent
common bile duct obstruction
endoscopic retrograde cholangiopancreatography
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical