- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02461147
Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration
Initial Cholecystectomy With Intraoperative Cholangiography for Patients at Intermediate Risk of Common Bile Duct Stone Migration : Prospective Validation and Analysis
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Geneva, Schweiz, 1205
- Geneva University Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Admission through emergency department for an acute gallstone-related condition (cholecystitis, gallstone pancreatitis, ascending cholangitis, suspicion of gallstone migration, choledocholithiasis)
Exclusion Criteria:
- Severe sepsis or septic shock
- contra-indication to surgery
- previous surgery interfering with common bile duct assessment procedures (roux-en-y gastric bypass, etc.)
- previous cholecystectomy
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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.
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cf. arm/group description.
This intervention is not assigned by the investigators: it is the standard treatment at the investigators institution.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Length of hospital stay [days]
Zeitfenster: 1-100 days
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1-100 days
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Number of common bile duct investigations [N]
Zeitfenster: Anytime during hospital stay, an expected average of 7 days
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These include number of endoscopic ultrasounds (EUS), magnetic cholangio-pancreatography (MRCP) and endoscopic retrograde cholangio-pancreatography (ERCP) performed during the patient's hospital stay
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Anytime during hospital stay, an expected average of 7 days
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Common bile duct clearance rate [%]
Zeitfenster: This outcome will be assessed after each ERCP performed during hospital stay, an expected average of 7 days
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Percentage of patients where common bile duct (CBD) clearance was achieved after ERCP (did not require surgical exploration because of ERCP failure)
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This outcome will be assessed after each ERCP performed during hospital stay, an expected average of 7 days
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Morbidity
Zeitfenster: From admission up to 6 months after hospital discharge
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Morbidity will be assessed for each patient according to the Dindo-Clavien classification of surgical complications, including death.
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From admission up to 6 months after hospital discharge
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Pouya Iranmanesh, MD, Geneva University Hospital, Division of Digestive Surgery
- Studienleiter: Christian Toso, MD-PhD, Geneva University Hospital, Division of Digestive Surgery
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Pathologische Zustände, Anatomisch
- Erkrankungen der Gallenblase
- Erkrankungen der Gallenwege
- Erkrankungen der Bauchspeicheldrüse
- Gallengangserkrankungen
- Allgemeine Gallengangserkrankungen
- Kalkül
- Cholezystitis
- Pankreatitis
- Cholangitis
- Gallensteine
- Cholelithiasis
- Cholezystolithiasis
- Choledocholithiasis
Andere Studien-ID-Nummern
- CCK first validation
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .