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

Naval Military Medical University

Status: Completed

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

Treatments: Device: Fully covered self-expanding metal stents; Device: single plastic stent; Device: Multiple plastic stents

Study type: Observational

Funder types: Other

Identifiers

NCT06981975

SOLID (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

94 participants in 3 patient groups

single plastic stent

Description:

This cohort consists of patients diagnosed with chronic pancreatitis who underwent endoscopic biliary stenting using single plastic stents to treat benign biliary strictures.

Treatment:

Device: single plastic stent

multiple plastic stents

Description:

This cohort consists of patients diagnosed with chronic pancreatitis who underwent endoscopic biliary stenting using multiple plastic stents to treat benign biliary strictures.

Treatment:

Device: Multiple plastic stents

Fully covered self-expanding metal stent

Description:

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.

Treatment:

Device: Fully covered self-expanding metal stents