Clinical trial NCT06981975: Long-Term Outcomes of Different Stents for Benign Biliary Strictures Caused by Chronic Pancreatitis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Benign Biliary Strictures
Stenting Treatment
ERCP
ESWL
Keywords: Benign Biliary Strictures
Biliary Stenting
Chronic Pancreatitis
Plastic Stents
Self-Expandable Metallic Stents
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 94
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent endoscopic biliary stenting for the management of Benign biliary strictures secondary to chronic pancreatitis

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Long-term clinical success
timeFrame: 14 year follow up
Secondary outcomes:
measure: Early clinical success
timeFrame: 1 year since the initial procedure
measure: Number of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures
timeFrame: 14 year follow up
measure: Total number of stents placed
timeFrame: 14 year follow up
measure: Total stenting time
timeFrame: 14 year follow up
measure: Technical success
timeFrame: 14 year follow up
measure: Stricture recurrence
timeFrame: 14 year follow up
measure: Procedure- or device-related adverse events
timeFrame: 14 year follow-up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.