Common Bile Duct StrictureNCT04503291
Comparison Between Transpapillary and Suprapapillary Metal Stent
A study testing Metal stent placement in people with Common Bile Duct Stricture, run by Bucheon St. Mary's Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Common Bile Duct Stricture
- What is being tested?
- Metal stent placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jan 2021to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with common bile duct obstruction due to malignancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jae Hyuck Chang
Bucheon-si, Kyunggi, 14647
Jae H Chang, PhD, 82323407086, wwjjaang@hanmail.net
About this study
Official title: 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.
Read the 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.
- Conditions
- Common Bile Duct Stricture
- Being tested
- Metal stent placement
- Keywords
- metal stent, common bile duct obstruction, endoscopic retrograde cholangiopancreatography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metal stent placementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| supra-papillary metal stent group | Experimental | The distal ends of metal stents are located above the major papilla in the common bile duct. Receives: Procedure: Metal stent placement |
| trans-papillary metal stent group | Active comparator | The distal ends of metal stents are located below the major papilla in the duodenum. Receives: Procedure: Metal stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent function maintenance duration
jaundice free survival
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
stone or sludge occurrence
in-stent or above stent bile duct stone formation
Measured: 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
Measured: through study completion, an average of 1 year
acute cholangitis occurrence
after procedure acute cholangitis occurrence rate
Measured: through study completion, an average of 1 year
stent migration rate
spontaneous migration rate
Measured: through study completion, an average of 1 year
overall survival
duration between stent placement and death
Measured: From date of randomization until the date of date of death from any cause, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start4 Jan 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion12 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. supra-papillary metal stent group 2. trans-papillary metal stent group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bucheon St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, Incheon St.Mary's Hospital, St Vincent's Hospital
- Responsible party
- Principal investigator, Jae Hyuck Chang, Bucheon St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503291
- Sponsor's protocol ID
- BucheonStMarys
- Status last verified
- Jul 2022
- First submitted
- 30 Jul 2020
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Transpapillary and Suprapapillary Metal Stent Placement With Endoscopic Sphincterotomy in Common Bile Duct Malignant Obstruction: Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04503291
- Acronym / sponsor ID
- BucheonStMarys
- Conditions
- Common Bile Duct Stricture
- Keywords
- metal stent, common bile duct obstruction, endoscopic retrograde cholangiopancreatography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Bucheon St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, Incheon St.Mary's Hospital, St Vincent's Hospital
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 12 Dec 2023 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. supra-papillary metal stent group 2. trans-papillary metal stent group
| Arm | Type | Receives |
|---|---|---|
| supra-papillary metal stent group | Experimental | Procedure: Metal stent placementThe distal ends of metal stents are located above the major papilla in the common bile duct. |
| trans-papillary metal stent group | Active comparator | Procedure: Metal stent placementThe distal ends of metal stents are located below the major papilla in the duodenum. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with common bile duct obstruction due to malignancy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metal stent placementNon-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. | Procedure or surgery | supra-papillary metal stent group, trans-papillary metal stent group |
Primary outcome
Stent function maintenance duration
Time frame: through study completion, an average of 1 year
jaundice free survival
5 secondary outcomes
stone or sludge occurrence
Time frame: through study completion, an average of 1 year
in-stent stenosis or tumor overgrowth
Time frame: through study completion, an average of 1 year
acute cholangitis occurrence
Time frame: through study completion, an average of 1 year
stent migration rate
Time frame: through study completion, an average of 1 year
overall survival
Time frame: From date of randomization until the date of date of death from any cause, assessed up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metal stent placement in people with Common Bile Duct Stricture, run by Bucheon St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Hyuck Chang, Ph, Dr (82-32-340-7086, wwjjaang@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent function maintenance duration (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.