NCT06981975

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

Long-term Outcomes of Different Stents for Benign Biliary Stricture Secondary to Chronic Pancreatitis: A Comparative Study Based on a Large Prospective Cohort

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 94 (actual)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	single plastic stent	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.
DEVICE	Multiple plastic stents	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.
DEVICE	Fully covered self-expanding metal stents	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.

Timeline

• Start date: 2025-05-24
• Primary completion: 2025-06-03
• Completion: 2025-06-03
• First posted: 2025-05-21
• Last updated: 2025-06-04

Locations

1 site across 1 country: China