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.
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 Type
OBSERVATIONAL
Enrollment
94
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.
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.
Changhai Hospital
Shanghai, Shanghai Municipality, China
Long-term clinical success
Being recurrence-free from the time of initial stent removal or spontaneous stent passage
Time frame: 14 year follow up
Early clinical success
Benign biliary stricture resolution within 1 year since the initial procedure
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 14 year follow up
Stricture recurrence
Abnormalities in liver function tests and the need for repeat intervention after a period of stent removal
Time frame: 14 year follow up
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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.
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.
Time frame: 14 year follow-up