Pancreaticobiilary DiseasesNCT04325152
Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP
A study testing FCSEMS plus Clip and FCSEMS in people with Pancreaticobiilary Diseases and Endoscopic Retrograde Cholangiopancreatography, run by Air Force Military Medical University, China at 5 sites in China.
Trial summary
Fully covered self-expandable metal stent (FCSEMS) has been widely used in ERCP patients with malignant or benign biliary stricture, difficult CBDS, post-EST bleeding, bile leak or perforation. Compared with uncovered SEMS, FCSEMS can be removed several months later and has the advantage of longer patency. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreaticobiilary Diseases, Endoscopic Retrograde Cholangiopancreatography
- What is being tested?
- FCSEMS plus Clip and FCSEMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 5 sitesChina
- Study dates
- 21 Oct 2019to 19 Nov 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Patients with ERCP indications who were suitable for FCSEMS placement, such as benign or malignant biliary stricture, difficult CBDS, biliary or papillary bleeding, bile leak or perforation etc.
Who cannot join
- Expected life span ≤6 months
- Considering tumor resection within 6 months
- Failed CBD cannulation
- Hilar stricture (Bismuth II, III and IV)
- CBD dilating by a balloon catheter with diameter≥8mm
- Inserting the whole FCSEMS into CBD and the distal end of FCSEMS invisible in endoscopic view
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- Maximal CBD diameter ≤6mm
- Pregnancy or lactation
- Unable to provide informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Chongqing, 400010
Huaihe Hospital of Henan University
Kaifeng, Henan, 475000
The Third Affiliated Hospital of Second Military Medical University
Shanghai, 200433
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Xiamen Humanity Hospital
Xiamen, Fujian, 361001
About this study
Official title: Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP: a Randomized Controlled Trial
Fully covered self-expandable metal stent (FCSEMS) has been widely used in ERCP patients with malignant or benign biliary stricture, difficult CBDS, post-EST bleeding, bile leak or perforation. Compared with uncovered SEMS, FCSEMS can be removed several months later and has the advantage of longer patency. Proximal or distal migration is one of major disadvantages of FCSEMS. The migration rate ranged from 7.0%-33% in previous reports.
We hypothesized that the fixation of the distal end of FCSEMS by a metal clip could decrease the migration rate and migration-related cholangitis.
- Being tested
- FCSEMS plus Clip, FCSEMS
- Keywords
- ERCP, Fully Covered Self-expandable Metal Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCSEMS plus ClipDevice
After successful cannulation, a 10mm FCSEMS with the length of 6cm or 8cm were inserted into CBD. Then a metal clip was used to fix the distal end of FCSEMS with the duodenal mucosa adjacent to papilla.
FCSEMSDevice
FCSEMS was released as the same as mentioned above. No fixating method was used.
| Study group | Role | What they receive |
|---|---|---|
| FCSEMS+Clip | Experimental | After successful cannulation, a 10mm FCSEMS with the length of 6cm or 8cm were inserted into CBD. One to two centimeters of distal end of FCSEMS was left outside of the papilla and the stent was released. Then a metal clip was used to fix the distal end of FCSEMS with the duodenal mucosa adjacent to papilla. Receives: Device: FCSEMS plus Clip |
| FCSEMS | Sham comparator | FCSEMS was released as the same as mentioned above. No fixating method was used. Receives: Device: FCSEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration rate of FCSEMS
The proportion of patients who had stent migration after placing FCSEMS, which was defined as radiological or endoscopic evidence of distal or proximal migration within 6 months after placing FCSEMS.
Measured: 6 months
Secondary outcomes (4)
Distal migration rate
The proportion of patients who had distal migration of FCSEMS, which was defined as radiological or endoscopic evidence of fully or partially distal migration of the stent out of CBD during follow up.
Fully distal migration: The whole stent was out of CBD or disappeared in fluoroscopy.
Partially distal migration: More than half length of FCSEMS was visible in endoscopic view.
Measured: 6 months
Proximal migration rate
The proportion of patients who had proximal migration of FCSEMS, which was defined as radiological or endoscopic evidence of fully or partially proximal migration of the stent into CBD during follow up.
Fully proximal migration: The whole stent was in CBD and the distal end was not visible.
Partially proximal migration: Less than 0.5cm of distal end of FCSEMS was visible in endoscopic view.
Measured: 6 months
Rate of cholangitis after FCSEMS placement
The proportion of patients who had the complication of cholangitis during follow up, due to stent migration, tumor/tissue ingrowth or food impaction.
Measured: 6 months
Complications related to stent removal
Including failed extraction of the stent, bleeding or cholangitis which needed further management after stent removal.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start21 Oct 2019
- Primary completion19 Nov 2022
- Study completion19 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreaticobiilary DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, Huaihe Hospital of Henan University, Xiamen Humanity Hospital, Eastern Hepatobiliary Surgery Hospital
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325152
- Sponsor's protocol ID
- KY20200113-2
- Status last verified
- Jan 2024
- First submitted
- 26 Mar 2020
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Shi X, Luo H, Ren G, Wang X, Zhao J, Li H, Ning B, Yi H, Zhong L, Zhang R, Ni Z, Liang S, Xia M, Hu B, Pan Y, Fan D. Effects of Clip Anchoring on Preventing Migration of Fully Covered Self-Expandable Metal Stent in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: A Multicenter, Randomized Controlled Study. Am J Gastroenterol. 2024 Oct 1;119(10):2028-2035. doi: 10.14309/ajg.0000000000002813. Epub 2024 Apr 15.
PubMed 38619136
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04325152
- Acronym / sponsor ID
- KY20200113-2
- Keywords
- ERCP, Fully Covered Self-expandable Metal Stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, Huaihe Hospital of Henan University, Xiamen Humanity Hospital, Eastern Hepatobiliary Surgery Hospital
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 19 Nov 2022 (actual)
- Study completion
- 19 Nov 2022 (actual)
- First posted
- 27 Mar 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.
Fully covered self-expandable metal stent (FCSEMS) has been widely used in ERCP patients with malignant or benign biliary stricture, difficult CBDS, post-EST bleeding, bile leak or perforation. Compared with uncovered SEMS, FCSEMS can be removed several months later and has the advantage of longer patency. Proximal or distal migration is one of major disadvantages of FCSEMS. The migration rate ranged from 7.0%-33% in previous reports.
We hypothesized that the fixation of the distal end of FCSEMS by a metal clip could decrease the migration rate and migration-related cholangitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCSEMS+Clip | Experimental | Device: FCSEMS plus ClipAfter successful cannulation, a 10mm FCSEMS with the length of 6cm or 8cm were inserted into CBD. One to two centimeters of distal end of FCSEMS was left outside of the papilla and the stent was released. Then a metal clip was used to fix the distal end of FCSEMS with the duodenal mucosa adjacent to papilla. |
| FCSEMS | Sham comparator | Device: FCSEMSFCSEMS was released as the same as mentioned above. No fixating method was used. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80
- Patients with ERCP indications who were suitable for FCSEMS placement, such as benign or malignant biliary stricture, difficult CBDS, biliary or papillary bleeding, bile leak or perforation etc.
Key exclusion criteria (9 listed)
- Expected life span ≤6 months
- Considering tumor resection within 6 months
- Failed CBD cannulation
- Hilar stricture (Bismuth II, III and IV)
- CBD dilating by a balloon catheter with diameter≥8mm
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 |
|---|---|---|
| FCSEMS plus ClipAfter successful cannulation, a 10mm FCSEMS with the length of 6cm or 8cm were inserted into CBD. Then a metal clip was used to fix the distal end of FCSEMS with the duodenal mucosa adjacent to papilla. | Device | FCSEMS+Clip |
| FCSEMSFCSEMS was released as the same as mentioned above. No fixating method was used. | Device | FCSEMS |
Primary outcome
Migration rate of FCSEMS
Time frame: 6 months
The proportion of patients who had stent migration after placing FCSEMS, which was defined as radiological or endoscopic evidence of distal or proximal migration within 6 months after placing FCSEMS.
4 secondary outcomes
Distal migration rate
Time frame: 6 months
Proximal migration rate
Time frame: 6 months
Rate of cholangitis after FCSEMS placement
Time frame: 6 months
Complications related to stent removal
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 38619136Wang X, Shi X, Luo H, Ren G, Wang X, Zhao J, Li H, Ning B, Yi H, Zhong L, Zhang R, Ni Z, Liang S, Xia M, Hu B, Pan Y, Fan D. Effects of Clip Anchoring on Preventing Migration of Fully Covered Self-Expandable Metal Stent in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: A Multicenter, Randomized Controlled Study. Am J Gastroenterol. 2024 Oct 1;119(10):2028-2035. doi: 10.14309/ajg.0000000000002813. Epub 2024 Apr 15.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FCSEMS plus Clip and FCSEMS in people with Pancreaticobiilary Diseases and Endoscopic Retrograde Cholangiopancreatography, run by Air Force Military Medical University, China at 5 sites in China.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migration rate of FCSEMS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04325152, which also lists 1 linked publication.
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 17 Jan 2024.