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The goal of this study is to compare safety and efficacy of laparoscopic cholecystectomy versus wait-and-see policy after endoscopic removal of common bile duct stones in elderly. The primary endpoint is a composite outcome: Death or major postoperative complications or recurrent biliary disease within 1 year after randomization.
Elderly patients with common bile duct stones are asked to participate this randomized trial after successful endoscopic removal of common bile duct stones. The hypothesis of the study is that wait-and-see policy is non-inferior to laparoscopic cholecystectomy. Four hundred patients are randomized 1:1 to either laparoscopic cholecystectomy group or wait-and see group. Cholecystectomy is done on the same admission or within two weeks after randomization. One interim analysis is planned for the trial after 100 randomized patients to assess safety. The trial is terminated if there is a statistically significant difference in primary outcome with p<0.001 (chi-square test) between the study arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecystectomy | Active Comparator | Laparoscopic cholecystectomy is done within 2 weeks after endoscopic removal of common bile duct stones. |
|
| Wait-and-see | No Intervention | After endoscopic removal of common bile duct stones, patients are managed non-operatively. During the follow-up cholecystectomy will be available on demand. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic cholecystectomy | Procedure | Laparoscopic cholecystectomy within 2 weeks after endoscopic removal of common bile duct stone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with composite outcome of death, major complication or recurrent biliary event | The primary outcome is a composite outcome including death within 1 year after randomization, the occurrence of major complications within 30 days from surgery and recurrent biliary event requiring hospitalization. within 1 year after randomization. A recurrent biliary event refers to cholecystitis, pancreatitis, cholangitis, or bile duct stones. Major complications were defined as infectious, cardiovascular and pulmonary complications, and surgical complication (Clavien-Dindo grade III or higher) | From randomization to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of good days | Number of days alive and out of hospital | From randomization to 1 year |
| EQ VAS value | Quality of life is measured using EuroQOL EQ-5D-5L instrument, EQ VAS values are compared. 0 represents the worst health a person can imagine and 100 represents the the best health a person can imagine. EQ-5D-5L dimension responses are reported as a descriptive data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Panu Mentula, MD, PhD | Contact | +358504270183 | panu.mentula@hus.fi | |
| Päivi Siironen, MD, PhD | Contact | +358504271343 | paivi.siironen@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Panu Mentula, MD, PhD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital, Jorvi | Recruiting | Espoo | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36524923 | Background | Kivivuori A, Mattila L, Siiki A, Laukkarinen J, Rantanen T, Ukkonen M. Wait-and-see strategy is justified after ERCP and endoscopic sphincterotomy in elderly patients with common biliary duct stones. J Trauma Acute Care Surg. 2023 Mar 1;94(3):443-447. doi: 10.1097/TA.0000000000003852. Epub 2022 Dec 14. | |
| 17111279 | Background |
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| at 30 days, 180 days and 365 days after randomization |
| Survival | Survival is measured using Kaplan-Meier analysis | From randomization to 1 year |
| Number of patients with major complications | Number of patients with major complications defined as infectious, cardiovascular, and pulmonary complications, and surgical complication (Clavien-Dindo grade III or higher) | From randomization to 1 year |
| Number of patients with recurrent biliary event | Number of patients with recurrent biliary event (cholecystitis, pancreatitis, cholangitis, or symptomatic bile duct stones) | From randomization to 1 year |
| Composite outcome of death or occurrence of major complications or recurrent biliary event requiring hospitalization | The same as primary outcome, but after 2 years follow-up | From randomization to 2 years |
| Number of patients with uncomplicated biliary pain or post cholecystectomy pain | Uncomplicated biliary pain/ post cholecystectomy pain. Specific 5 criteria of biliary pain include : 1. severe pain attacks, 2. lasting 15 to 30 minutes or longer, 3. location in epigastrium or right upper quadrant, 4. pain radiating to the back, 5. a positive pain response to simple analgesics | At 30, 180 and 365 days after randomization |
| Healthcare costs | Healthcare costs related to bile stones; including laboratory tests, imaging (ultra sound, computer tomography, magnetic resonance imaging), procedures (Endoscopic Retrograde Cholangio Pancreatography (ERCP), laparoscopic cholecystectomy), emergency visits and hospital days. | From randomization to 1 year |
| Kanta-Häme Central Hospital | Not yet recruiting | Hämeenlinna | Finland |
| Helsinki University Hospital, Meilahti | Recruiting | Helsinki | Finland |
|
| Pohjois-Karjala Central Hospital | Not yet recruiting | Joensuu | Finland |
| Keski-Suomi Central Hospital | Not yet recruiting | Jyväskylä | Finland |
| Kymenlaakso Central Hospital | Not yet recruiting | Kotka | Finland |
| Kuopio University Hospital | Not yet recruiting | Kuopio | Finland |
| Päijät-Häme Central Hospital | Not yet recruiting | Lahti | Finland |
| Oulu University Hospital | Not yet recruiting | Oulu | Finland |
| Tampere University Hospital | Not yet recruiting | Tampere | Finland |
| Turku University Hospital | Not yet recruiting | Turku | Finland |
| Vaasa Central Hospital | Not yet recruiting | Vaasa | Finland |
| Costi R, DiMauro D, Mazzeo A, Boselli AS, Contini S, Violi V, Roncoroni L, Sarli L. Routine laparoscopic cholecystectomy after endoscopic sphincterotomy for choledocholithiasis in octogenarians: is it worth the risk? Surg Endosc. 2007 Jan;21(1):41-7. doi: 10.1007/s00464-006-0169-2. Epub 2006 Nov 16. |
| 12241833 | Background | Boerma D, Rauws EA, Keulemans YC, Janssen IM, Bolwerk CJ, Timmer R, Boerma EJ, Obertop H, Huibregtse K, Gouma DJ. Wait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial. Lancet. 2002 Sep 7;360(9335):761-5. doi: 10.1016/S0140-6736(02)09896-3. |
| 33813631 | Background | Bass GA, Gillis AE, Cao Y, Mohseni S; European Society for Trauma and Emergency Surgery (ESTES) Cohort Studies Group. Patients over 65 years with Acute Complicated Calculous Biliary Disease are Treated Differently-Results and Insights from the ESTES Snapshot Audit. World J Surg. 2021 Jul;45(7):2046-2055. doi: 10.1007/s00268-021-06052-0. Epub 2021 Apr 3. |
| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| D002769 | Cholelithiasis |
| 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 |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
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