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Initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, has been implemented at the investigators institution as the standard management strategy for patients at intermediate risk of common bile duct stone migration, following a randomized controlled trial previously published by the same investigators team. The aim of this study is to prospectively analyze the outcomes of this strategy.
A previous randomized controlled trial comparing initial cholecystectomy with intraoperative cholangiogram (IOC) versus common bile duct (CBD) assessment and subsequent cholecystectomy for patients admitted in the emergency room with an acute gallstone-related condition and with an intermediate risk of common bile duct stone was performed by the investigators. This study had been registered on Clinicaltrials.gov as well and had shown that a strategy with initial cholecystectomy significantly decreased the length of hospital stay and the number of CBD investigations procedures.
Initial cholecystectomy with IOC is now the standard management strategy for these patients in the investigators hospital. The goal of this study is to perform a prospective validation of this strategy and to analyze if the results obtained in the previously mentioned randomized controlled trial are confirmed on a larger patients cohort. This study will be observational, since the intervention (initial cholecystectomy) is not assigned by the investigators, but is already a standard treatment strategy at our institution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Validation cohort | All patients of the study (single group, single arm) will undergo initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, according to the standard protocol of treatment previously implemented at the investigators institution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecystectomy with intraoperative cholangiogram | Procedure | cf. arm/group description. This intervention is not assigned by the investigators: it is the standard treatment at the investigators institution. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay [days] | 1-100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of common bile duct investigations [N] | These include number of endoscopic ultrasounds (EUS), magnetic cholangio-pancreatography (MRCP) and endoscopic retrograde cholangio-pancreatography (ERCP) performed during the patient's hospital stay | Anytime during hospital stay, an expected average of 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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All patients admitted through the emergency department for an acute gallstone-related condition.
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| Name | Affiliation | Role |
|---|---|---|
| Pouya Iranmanesh, MD | Geneva University Hospital, Division of Digestive Surgery | Principal Investigator |
| Christian Toso, MD-PhD | Geneva University Hospital, Division of Digestive Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospital | Geneva | 1205 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25005650 | Result | Iranmanesh P, Frossard JL, Mugnier-Konrad B, Morel P, Majno P, Nguyen-Tang T, Berney T, Mentha G, Toso C. Initial cholecystectomy vs sequential common duct endoscopic assessment and subsequent cholecystectomy for suspected gallstone migration: a randomized clinical trial. JAMA. 2014 Jul;312(2):137-44. doi: 10.1001/jama.2014.7587. | |
| 25399287 |
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| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| D002764 | Cholecystitis |
| D002761 | Cholangitis |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Common bile duct clearance rate [%] |
Percentage of patients where common bile duct (CBD) clearance was achieved after ERCP (did not require surgical exploration because of ERCP failure) |
| This outcome will be assessed after each ERCP performed during hospital stay, an expected average of 7 days |
| Morbidity | Morbidity will be assessed for each patient according to the Dindo-Clavien classification of surgical complications, including death. | From admission up to 6 months after hospital discharge |
| Iranmanesh P, Frossard JL, Toso C. Treatment for patients at intermediate risk of a common duct stone--reply. JAMA. 2014 Nov 19;312(19):2043-4. doi: 10.1001/jama.2014.13425. No abstract available. |
| 25451659 | Result | Iranmanesh P, Frossard JL, Toso C. Reply: To PMID 25451658. Gastroenterology. 2015 Jan;148(1):252. doi: 10.1053/j.gastro.2014.11.016. Epub 2014 Nov 21. No abstract available. |
| D002769 | Cholelithiasis |
| D005705 | Gallbladder Diseases |