Long-Term Outcomes of Different Stents for Benign Biliary Strictures Caused by Chronic Pancreatitis

NCT06981975 | Completed DMC

• 1 other identifier: SOLID
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pancreatitis; Benign Biliary Strictures; Stenting Treatment; ERCP; ESWL

Keywords

Benign Biliary Strictures; Biliary Stenting; Chronic Pancreatitis; Plastic Stents; Self-Expandable Metallic Stents

Outcome Measures

Primary Outcomes (1)

• Long-term clinical success

  Being recurrence-free from the time of initial stent removal or spontaneous stent passage

  14 year follow up

Secondary Outcomes (7)

• Early clinical success

  1 year since the initial procedure

• Number of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures

  14 year follow up

• Total number of stents placed

  14 year follow up

• Total stenting time

  14 year follow up

• Technical success

  14 year follow up

Study Arms (3)

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.

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.

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.

Device: Fully covered self-expanding metal stents

Interventions

single plastic stent DEVICE

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.

Also known as: SPS

single plastic stent

Multiple plastic stents DEVICE

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.

Also known as: MPSs

multiple plastic stents

Fully covered self-expanding metal stents DEVICE

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.

Also known as: fcSEMS

Fully covered self-expanding metal stent

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent endoscopic biliary stenting for the management of Benign biliary strictures secondary to chronic pancreatitis

You may qualify if:

• 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

You may not qualify if:

• Patients diagnosed with pancreatic cancer within two years following the diagnosis of CP.
• Incomplete Records of endoscopic biliary stenting treatment

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (3)

• 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.

  PMID: 25590182 BACKGROUND

• Cote 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.

  PMID: 27002446 BACKGROUND

• Ramchandani 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.

  PMID: 33741314 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 21, 2025
• Study Start: May 24, 2025
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)