Benign Biliary Strictures, Chronic Pancreatitis, ERCP, ESWL, Stenting Treatment
Conditions
Keywords
Benign Biliary Strictures, Biliary Stenting, Chronic Pancreatitis, Plastic Stents, Self-Expandable Metallic Stents
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.
Interventions
DEVICEsingle 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.
DEVICEMultiple 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.
DEVICEFully 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.
Sponsors
Changhai Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term clinical success | 14 year follow up | Being recurrence-free from the time of initial stent removal or spontaneous stent passage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures | 14 year follow up | Number of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures during the initial treatment period (excluding ERCP treatment after stricture recurrence) |
| Total number of stents placed | 14 year follow up | Total number of stents placed during the initial treatment period (excluding stents placed for stricture recurrence) |
| Total stenting time | 14 year follow up | Total stents placement duration of the initial treatment period (from stent placement to stent removal or spontaneous passage) |
| Early clinical success | 1 year since the initial procedure | Benign biliary stricture resolution within 1 year since the initial procedure |
| Stricture recurrence | 14 year follow up | Abnormalities in liver function tests and the need for repeat intervention after a period of stent removal |
| Procedure- or device-related adverse events | 14 year follow-up | Device or procedure related serious adverse events from the initial stent placement procedure to the 14 year follow-up. |
| Technical success | 14 year follow up | Technical success defined as the ability to deploy the stent(s) in satisfactory position during initial stent placement procedure. |
Countries
China
Outcome results
None listed