Chronic PancreatitisSOLIDNCT06981975
Long-Term Outcomes of Different Stents for Benign Biliary Strictures Caused by Chronic Pancreatitis
An observational study of Chronic Pancreatitis and Benign Biliary Strictures, run by Changhai Hospital at 1 site in China.
Trial summary
This observational study aims to observe and compare the long-term effectiveness and safety of different types of stents for benign biliary strictures secondary to chronic pancreatitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pancreatitis, Benign Biliary Strictures, Stenting Treatment
- What is being tested?
- single plastic stent, Multiple plastic stents and Fully covered self-expanding metal stents
- Type of treatment
- Medical device
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2025to 3 Jun 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent endoscopic biliary stenting for the management of Benign biliary strictures secondary to chronic pancreatitis
Who may be able to join
- Diagnosis of chronic pancreatitis
- Benign biliary strictures secondary to chronic pancreatitis
- Patients who have undergone endoscopic biliary stenting for the management of BBS between January 2011 and December 2021.
- Complete Treatment Records
Who cannot join
- Patients diagnosed with pancreatic cancer within two years following the diagnosis of CP.
- Incomplete Records of endoscopic biliary stenting treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcomes of Different Stents for Benign Biliary Stricture Secondary to Chronic Pancreatitis: A Comparative Study Based on a Large Prospective Cohort
This observational study aims to observe and compare the long-term effectiveness and safety of different types of stents for benign biliary strictures secondary to chronic pancreatitis.
Read the detailed description
Chronic pancreatitis (CP) is a debilitating condition that often results in the development of benign biliary strictures (BBS), which significantly contribute to morbidity. BBS are prevalent among a substantial number of CP patients, causing complications such as cholestasis and jaundice. Endoscopic biliary stenting has traditionally been the primary treatment for BBS, initially employing single plastic stents (SPS), which yielded suboptimal outcomes.
Nowadays, fully covered self-expanding metal stents (fcSEMS) and multiple plastic stents (MPS) are considered the first line therapies for BBS caused by CP. However, advancements in lithotripsy and endoscopic retrograde cholangiopancreatography have led to a marked increase in the successful rate of pancreatic duct decompression. This progress necessitates a reevaluation of the effectiveness of SPS.
The objective of this study is to assess and compare the long-term outcomes of various stenting types in patients with BBS due to CP. It is expected that the study's results will provide valuable insights into the optimal stenting strategies for BBS in CP patients. These insights have the potential to greatly influence clinical practice and guide the development of treatment guidelines.
- Conditions
- Chronic Pancreatitis, Benign Biliary Strictures, Stenting Treatment, ERCP, ESWL
- Being tested
- single plastic stent, Multiple plastic stents, Fully covered self-expanding metal stents
- Keywords
- Benign Biliary Strictures, Biliary Stenting, Chronic Pancreatitis, Plastic Stents, Self-Expandable Metallic Stents
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single plastic stentDevice
Also called SPS
Endoscopic biliary stenting was performed using standard techniques. The maximum bile duct diameter and length of stricture were measured after visualization on x-ray films by retrograde cholangiography. If necessary, sphincterotomy or dilation of the stricture was performed before insertion of the stent. Endoscopic stenting comprised the placement of a single plastic stent. Stents were exchanged at regular intervals or when signs of stent dysfunction were present. If imaging evaluation demonstrated spontaneous passage of the stent with resolution of the stricture, ERCP for stent retrieval was no longer necessary.
Multiple plastic stentsDevice
Also called MPSs
Endoscopic biliary stenting was performed using standard techniques. The maximum bile duct diameter and length of stricture were measured after visualization on x-ray films by retrograde cholangiography. If necessary, sphincterotomy or dilation of the stricture was performed before insertion of the stent. Endoscopic stenting comprised the placement of multiple plastic stents. Stents were exchanged at regular intervals or when signs of stent dysfunction were present. If imaging evaluation demonstrated spontaneous passage of the stent with resolution of the stricture, ERCP for stent retrieval was no longer necessary.
Fully covered self-expanding metal stentsDevice
Also called fcSEMS
Endoscopic biliary stenting was performed using standard techniques. The maximum bile duct diameter and length of stricture were measured after visualization on x-ray films by retrograde cholangiography. If necessary, sphincterotomy or dilation of the stricture was performed before insertion of the stent. Endoscopic stenting comprised the placement of fully covered self-expanding metal stents (fcSEMS) . Stents were exchanged at regular intervals or when signs of stent dysfunction were present. If imaging evaluation demonstrated spontaneous passage of the stent with resolution of the stricture, ERCP for stent retrieval was no longer necessary.
| Study group | Role | What they receive |
|---|---|---|
| single plastic stent | This cohort consists of patients diagnosed with chronic pancreatitis who underwent endoscopic biliary stenting using single plastic stents to treat benign biliary strictures. Receives: Device: single plastic stent | |
| multiple plastic stents | This cohort consists of patients diagnosed with chronic pancreatitis who underwent endoscopic biliary stenting using multiple plastic stents to treat benign biliary strictures. Receives: Device: Multiple plastic stents | |
| Fully covered self-expanding metal stent | This cohort consists of patients diagnosed with chronic pancreatitis who underwent endoscopic biliary stenting using ffully covered self-expanding metal stent to treat benign biliary strictures. Receives: Device: Fully covered self-expanding metal stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term clinical success
Being recurrence-free from the time of initial stent removal or spontaneous stent passage
Measured: 14 year follow up
Secondary outcomes (7)
Early clinical success
Benign biliary stricture resolution within 1 year since the initial procedure
Measured: 1 year since the initial procedure
Number of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures
Number of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures during the initial treatment period (excluding ERCP treatment after stricture recurrence)
Measured: 14 year follow up
Total number of stents placed
Total number of stents placed during the initial treatment period (excluding stents placed for stricture recurrence)
Measured: 14 year follow up
Total stenting time
Total stents placement duration of the initial treatment period (from stent placement to stent removal or spontaneous passage)
Measured: 14 year follow up
Technical success
Technical success defined as the ability to deploy the stent(s) in satisfactory position during initial stent placement procedure.
Measured: 14 year follow up
Stricture recurrence
Abnormalities in liver function tests and the need for repeat intervention after a period of stent removal
Measured: 14 year follow up
Procedure- or device-related adverse events
Device or procedure related serious adverse events from the initial stent placement procedure to the 14 year follow-up.
Measured: 14 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start24 May 2025
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981975
- Sponsor's protocol ID
- SOLID
- Acronym
- SOLID
- Status last verified
- Jun 2025
- First submitted
- 10 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haapamaki C, Kylanpaa L, Udd M, Lindstrom O, Gronroos J, Saarela A, Mustonen H, Halttunen J. Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis. Endoscopy. 2015 Jul;47(7):605-10. doi: 10.1055/s-0034-1391331. Epub 2015 Jan 15.
PubMed 25590182Cote GA, Slivka A, Tarnasky P, Mullady DK, Elmunzer BJ, Elta G, Fogel E, Lehman G, McHenry L, Romagnuolo J, Menon S, Siddiqui UD, Watkins J, Lynch S, Denski C, Xu H, Sherman S. Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1250-7. doi: 10.1001/jama.2016.2619.
PubMed 27002446Ramchandani M, Lakhtakia S, Costamagna G, Tringali A, Puspoek A, Tribl B, Dolak W, Deviere J, Arvanitakis M, van der Merwe S, Laleman W, Ponchon T, Lepilliez V, Gabbrielli A, Bernardoni L, Bruno MJ, Poley JW, Arnelo U, Lau J, Roy A, Bourke M, Kaffes A, Neuhaus H, Peetermans J, Rousseau M, Reddy DN. Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial. Gastroenterology. 2021 Jul;161(1):185-195. doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.
PubMed 33741314
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Different Stents for Benign Biliary Stricture Secondary to Chronic Pancreatitis: A Comparative Study Based on a Large Prospective Cohort
- ClinicalTrials.gov ID
- NCT06981975
- Acronym / sponsor ID
- SOLID / SOLID
- Conditions
- Chronic Pancreatitis, Benign Biliary Strictures, Stenting Treatment, ERCP, ESWL
- Keywords
- Benign Biliary Strictures, Biliary Stenting, Chronic Pancreatitis, Plastic Stents, Self-Expandable Metallic Stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 24 May 2025 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 21 May 2025 (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.
This observational study aims to observe and compare the long-term effectiveness and safety of different types of stents for benign biliary strictures secondary to chronic pancreatitis.
Detailed description
Chronic pancreatitis (CP) is a debilitating condition that often results in the development of benign biliary strictures (BBS), which significantly contribute to morbidity. BBS are prevalent among a substantial number of CP patients, causing complications such as cholestasis and jaundice. Endoscopic biliary stenting has traditionally been the primary treatment for BBS, initially employing single plastic stents (SPS), which yielded suboptimal outcomes.
Nowadays, fully covered self-expanding metal stents (fcSEMS) and multiple plastic stents (MPS) are considered the first line therapies for BBS caused by CP. However, advancements in lithotripsy and endoscopic retrograde cholangiopancreatography have led to a marked increase in the successful rate of pancreatic duct decompression. This progress necessitates a reevaluation of the effectiveness of SPS.
The objective of this study is to assess and compare the long-term outcomes of various stenting types in patients with BBS due to CP. It is expected that the study's results will provide valuable insights into the optimal stenting strategies for BBS in CP patients. These insights have the potential to greatly influence clinical practice and guide the development of treatment guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| single plastic stent | – | Device: single plastic stentThis cohort consists of patients diagnosed with chronic pancreatitis who underwent endoscopic biliary stenting using single plastic stents to treat benign biliary strictures. |
| multiple plastic stents | – | Device: Multiple plastic stentsThis cohort consists of patients diagnosed with chronic pancreatitis who underwent endoscopic biliary stenting using multiple plastic stents to treat benign biliary strictures. |
| Fully covered self-expanding metal stent | – | Device: Fully covered self-expanding metal stentsThis cohort consists of patients diagnosed with chronic pancreatitis who underwent endoscopic biliary stenting using ffully covered self-expanding metal stent to treat benign biliary strictures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent endoscopic biliary stenting for the management of Benign biliary strictures secondary to chronic pancreatitis
Key inclusion criteria (4 listed)
- Diagnosis of chronic pancreatitis
- Benign biliary strictures secondary to chronic pancreatitis
- Patients who have undergone endoscopic biliary stenting for the management of BBS between January 2011 and December 2021.
- Complete Treatment Records
Key exclusion criteria (2 listed)
- Patients diagnosed with pancreatic cancer within two years following the diagnosis of CP.
- Incomplete Records of endoscopic biliary stenting treatment
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 |
|---|---|---|
| single plastic stentAlso: SPSEndoscopic biliary stenting was performed using standard techniques. The maximum bile duct diameter and length of stricture were measured after visualization on x-ray films by retrograde cholangiography. If necessary, sphincterotomy or dilation of the stricture was performed before insertion of the stent. Endoscopic stenting comprised the placement of a single plastic stent. Stents were exchanged at regular intervals or when signs of stent dysfunction were present. If imaging evaluation demonstrated spontaneous passage of the stent with resolution of the stricture, ERCP for stent retrieval was no longer necessary. | Device | single plastic stent |
| Multiple plastic stentsAlso: MPSsEndoscopic biliary stenting was performed using standard techniques. The maximum bile duct diameter and length of stricture were measured after visualization on x-ray films by retrograde cholangiography. If necessary, sphincterotomy or dilation of the stricture was performed before insertion of the stent. Endoscopic stenting comprised the placement of multiple plastic stents. Stents were exchanged at regular intervals or when signs of stent dysfunction were present. If imaging evaluation demonstrated spontaneous passage of the stent with resolution of the stricture, ERCP for stent retrieval was no longer necessary. | Device | multiple plastic stents |
| Fully covered self-expanding metal stentsAlso: fcSEMSEndoscopic biliary stenting was performed using standard techniques. The maximum bile duct diameter and length of stricture were measured after visualization on x-ray films by retrograde cholangiography. If necessary, sphincterotomy or dilation of the stricture was performed before insertion of the stent. Endoscopic stenting comprised the placement of fully covered self-expanding metal stents (fcSEMS) . Stents were exchanged at regular intervals or when signs of stent dysfunction were present. If imaging evaluation demonstrated spontaneous passage of the stent with resolution of the stricture, ERCP for stent retrieval was no longer necessary. | Device | Fully covered self-expanding metal stent |
Primary outcome
Long-term clinical success
Time frame: 14 year follow up
Being recurrence-free from the time of initial stent removal or spontaneous stent passage
7 secondary outcomes
Early clinical success
Time frame: 1 year since the initial procedure
Number of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures
Time frame: 14 year follow up
Total number of stents placed
Time frame: 14 year follow up
Total stenting time
Time frame: 14 year follow up
Technical success
Time frame: 14 year follow up
Stricture recurrence
Time frame: 14 year follow up
Procedure- or device-related adverse events
Time frame: 14 year follow-up
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 4 Jun 2025.
- Background: PubMed 25590182Haapamaki C, Kylanpaa L, Udd M, Lindstrom O, Gronroos J, Saarela A, Mustonen H, Halttunen J. Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis. Endoscopy. 2015 Jul;47(7):605-10. doi: 10.1055/s-0034-1391331. Epub 2015 Jan 15.
- Background: PubMed 27002446Cote GA, Slivka A, Tarnasky P, Mullady DK, Elmunzer BJ, Elta G, Fogel E, Lehman G, McHenry L, Romagnuolo J, Menon S, Siddiqui UD, Watkins J, Lynch S, Denski C, Xu H, Sherman S. Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1250-7. doi: 10.1001/jama.2016.2619.
- Results publication: PubMed 33741314Ramchandani M, Lakhtakia S, Costamagna G, Tringali A, Puspoek A, Tribl B, Dolak W, Deviere J, Arvanitakis M, van der Merwe S, Laleman W, Ponchon T, Lepilliez V, Gabbrielli A, Bernardoni L, Bruno MJ, Poley JW, Arnelo U, Lau J, Roy A, Bourke M, Kaffes A, Neuhaus H, Peetermans J, Rousseau M, Reddy DN. Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial. Gastroenterology. 2021 Jul;161(1):185-195. doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis and Benign Biliary Strictures, run by Changhai Hospital at 1 site 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 4 inclusion and 2 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 4 Jun 2025. 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 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. 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?
Long-term clinical success (time frame: 14 year follow up). 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 NCT06981975, which also lists 3 linked publications.
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 4 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.