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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single plastic stent | This cohort consists of patients diagnosed with chronic pancreatitis who underwent endoscopic biliary stenting using single plastic stents to treat benign biliary strictures. |
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| multiple plastic stents | This cohort consists of patients diagnosed with chronic pancreatitis who underwent endoscopic biliary stenting using multiple plastic stents to treat benign biliary strictures. |
| |
| Fully covered self-expanding metal stent | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single plastic stent | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term clinical success | Being recurrence-free from the time of initial stent removal or spontaneous stent passage | 14 year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Early clinical success | Benign biliary stricture resolution within 1 year since the initial procedure | 1 year since the initial procedure |
| Number of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent endoscopic biliary stenting for the management of Benign biliary strictures secondary to chronic pancreatitis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25590182 | Background | 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. | |
| 27002446 |
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| Multiple plastic stents | Device | 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. |
|
|
| Fully covered self-expanding metal stents | Device | 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. |
|
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Number of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures during the initial treatment period (excluding ERCP treatment after stricture recurrence)
| 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) | 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) | 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. | 14 year follow up |
| Stricture recurrence | Abnormalities in liver function tests and the need for repeat intervention after a period of stent removal | 14 year follow up |
| 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. | 14 year follow-up |
| 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. |
| 33741314 | Result | 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. |
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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