SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis (SnapChole)
This study aims to understand how different treatment approaches for acute gallbladder inflammation (acute calculous cholecystitis) affect patient outcomes in real-world hospital settings.
Acute calculous cholecystitis is a common condition that occurs when gallstones block the gallbladder and cause infection or inflammation. In more severe cases, patients may develop organ dysfunction, and doctors must decide quickly how best to treat the condition. Treatment options include early surgery to remove the gallbladder, placement of a drainage tube, or treatment with antibiotics alone. The best approach is not always clear, especially for patients who are older, have other medical conditions, or are very unwell.
This study will collect information from hospitals around the world about how patients with severe gallbladder inflammation are treated as part of their usual care. No treatments are assigned by the study. All decisions are made by the patient's clinical team.
The goal is to compare outcomes between different treatment approaches in patients who could reasonably receive more than one option. The study will examine recovery, survival, need for additional procedures, and time spent in the hospital over 90 days.
The findings are intended to help doctors and patients better understand which treatment strategies may lead to better outcomes in different clinical situations, and to improve decision-making in emergency surgical care.
Przegląd badań
Status
Szczegółowy opis
SnapChole is an international, multicenter, prospective, time-bound observational platform study designed to evaluate management strategies and outcomes in adults with acute calculous cholecystitis. The study focuses on patients with severe disease, defined by the presence of organ dysfunction, in whom treatment decisions are influenced by both patient-level factors and system-level capability.
The study is conducted as a prospective clinical audit using routinely collected data and does not alter patient care. Participating centers enroll consecutive eligible patients during a predefined local accrual window. Data are recorded contemporaneously using standardized case report forms and transferred in deidentified form to a central coordinating database. Follow-up extends to 90 days from the index presentation.
The study architecture separates descriptive benchmarking from causal analysis. The full cohort provides a denominator population for characterization of treatment patterns, timing of interventions, and outcomes across centers and healthcare systems. Within this cohort, prespecified analytic subsets are defined at the point of clinical decision-making (time zero), corresponding to the moment at which the treating team determines that one or more management strategies are feasible.
Comparative analyses are structured to align eligibility, treatment assignment, and follow-up, consistent with a target trial emulation framework applied to observational data. Treatment strategies of interest include early cholecystectomy, gallbladder drainage as an initial approach, and antimicrobial-only management. Analyses are restricted to patients in whom the relevant strategies are simultaneously available, in order to reduce bias arising from differences in clinical eligibility or institutional capability.
Exposure is defined as completion of the assigned management strategy within a prespecified interval following the decision point, reflecting real-world delivery of care. Outcomes include days alive and out of hospital at 90 days, mortality, need for additional interventions, and time to achieved source control.
The study also incorporates complementary analyses, including benchmarking of care pathways, evaluation of patient-centered outcomes, and assessment of factors influencing clinical decision-making. Together, these components are intended to provide a comprehensive understanding of how management strategies are selected and how they relate to outcomes in severe acute calculous cholecystitis.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Gary A Bass, MD, PhD
- Numer telefonu: 2672168309
- E-mail: gary.bass@pennmedicine.upenn.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Stefano PB Cioffi, MD, PhD
- Numer telefonu: 2672168309
- E-mail: stefanopiero.cioffi@ospedaleniguarda.it
Lokalizacje studiów
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Hospital of the University of Pennsylvania
-
Kontakt:
- Gary A Bass, MD, PhD
- Numer telefonu: 2672168309
- E-mail: gary.bass@pennmedicine.upenn.edu
-
Kontakt:
- Christine
- Numer telefonu: +12152400454
- E-mail: garybassmd@gmail.com
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Age ≥18 years
- Presentation with suspected acute calculous cholecystitis
- Diagnosis confirmed prospectively according to Tokyo Guidelines 2018 (TG18) diagnostic criteria
- Classified as severe (TG18 Grade III) disease based on the presence of organ dysfunction
- Managed at a participating center during the study accrual period
Exclusion Criteria:
- Acalculous cholecystitis
- Isolated choledocholithiasis or acute cholangitis without cholecystitis
- Primary gallstone pancreatitis without concomitant acute cholecystitis
- Elective admission for chronic biliary symptoms
- Prior cholecystectomy
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
Full Platform Cohort
Consecutive adult patients presenting with acute calculous cholecystitis and meeting Tokyo Guidelines 2018 diagnostic criteria, including those with severe (Grade III) disease.
This cohort represents the full prospective denominator population and is used for benchmarking of treatment patterns, timing of interventions, and clinical outcomes under routine care.
No restrictions are applied based on treatment strategy eligibility.
|
|
Dual-Eligible Cohort (Surgery vs Drainage)
Subset of patients with severe acute calculous cholecystitis (Tokyo Guidelines 2018 Grade III) in whom both early cholecystectomy and gallbladder drainage are judged feasible and available at the attending surgeon-level decision point (time zero).
This cohort forms the analytic population for target trial emulation comparing operative source control with drainage-first strategies.
Eligibility is defined prior to treatment assignment.
|
|
Nonoperative-Eligible Cohort (Drainage vs Antibiotics)
Subset of patients with severe acute calculous cholecystitis (Tokyo Guidelines 2018 Grade III) not selected for immediate surgery but in whom both drainage-first and antimicrobial-only management are feasible at the time of decision.
This cohort forms the analytic population for target trial emulation comparing nonoperative management strategies.
Eligibility is defined at time zero prior to treatment initiation.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Days alive and out of hospital at 90 days
Ramy czasowe: 90 days from time zero (attending surgeon-level decision point)
|
Number of days the participant is alive and not hospitalized during the 90 days following time zero, defined as the attending surgeon-level decision point at which treatment strategy is assigned.
Higher values indicate better recovery.
|
90 days from time zero (attending surgeon-level decision point)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
All-cause mortality
Ramy czasowe: 90 days from time zero
|
Death from any cause within the specified follow-up period after time zero, defined as the attending surgeon-level decision point at which treatment strategy is assigned.
|
90 days from time zero
|
|
Failure of Source Control
Ramy czasowe: Within 90 days from time zero
|
Persistent or recurrent sepsis requiring escalation of intervention, including conversion to surgery, additional drainage procedures, or reoperation following the initial management strategy.
|
Within 90 days from time zero
|
|
Unplanned biliary reintervention
Ramy czasowe: within 90 days of time zero
|
Any unplanned procedural intervention related to biliary disease, including repeat drainage, operative intervention, or endoscopic procedures following the initial management strategy.
|
within 90 days of time zero
|
|
Length of hospital stay
Ramy czasowe: From hospital admission to hospital discharge, assessed up to 90 days from time zero
|
Total duration of the index hospital admission measured from admission to discharge.
|
From hospital admission to hospital discharge, assessed up to 90 days from time zero
|
|
Time to achieved source control
Ramy czasowe: From time zero to completion of source-control intervention, assessed up to 90 days
|
Elapsed time from time zero to completion of the definitive source-control intervention, including surgical or drainage procedures.
|
From time zero to completion of source-control intervention, assessed up to 90 days
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Krzesło do nauki: Gary A Bass, MD, PhD, University of Pennsylvania
Publikacje i pomocne linki
Publikacje ogólne
- Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Gimenez ME, de Santibanes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9.
- Pisano M, Allievi N, Gurusamy K, Borzellino G, Cimbanassi S, Boerna D, Coccolini F, Tufo A, Di Martino M, Leung J, Sartelli M, Ceresoli M, Maier RV, Poiasina E, De Angelis N, Magnone S, Fugazzola P, Paolillo C, Coimbra R, Di Saverio S, De Simone B, Weber DG, Sakakushev BE, Lucianetti A, Kirkpatrick AW, Fraga GP, Wani I, Biffl WL, Chiara O, Abu-Zidan F, Moore EE, Leppaniemi A, Kluger Y, Catena F, Ansaloni L. 2020 World Society of Emergency Surgery updated guidelines for the diagnosis and treatment of acute calculus cholecystitis. World J Emerg Surg. 2020 Nov 5;15(1):61. doi: 10.1186/s13017-020-00336-x.
- Bass GA, Kaplan LJ, Ryan EJ, Cao Y, Lane-Fall M, Duffy CC, Vail EA, Mohseni S. The snapshot audit methodology: design, implementation and analysis of prospective observational cohort studies in surgery. Eur J Trauma Emerg Surg. 2023 Feb;49(1):5-15. doi: 10.1007/s00068-022-02045-3. Epub 2022 Jul 15.
- Hernan MA, Robins JM. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available. Am J Epidemiol. 2016 Apr 15;183(8):758-64. doi: 10.1093/aje/kwv254. Epub 2016 Mar 18.
- Okamoto K, Suzuki K, Takada T, Strasberg SM, Asbun HJ, Endo I, Iwashita Y, Hibi T, Pitt HA, Umezawa A, Asai K, Han HS, Hwang TL, Mori Y, Yoon YS, Huang WS, Belli G, Dervenis C, Yokoe M, Kiriyama S, Itoi T, Jagannath P, Garden OJ, Miura F, Nakamura M, Horiguchi A, Wakabayashi G, Cherqui D, de Santibanes E, Shikata S, Noguchi Y, Ukai T, Higuchi R, Wada K, Honda G, Supe AN, Yoshida M, Mayumi T, Gouma DJ, Deziel DJ, Liau KH, Chen MF, Shibao K, Liu KH, Su CH, Chan ACW, Yoon DS, Choi IS, Jonas E, Chen XP, Fan ST, Ker CG, Gimenez ME, Kitano S, Inomata M, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: flowchart for the management of acute cholecystitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):55-72. doi: 10.1002/jhbp.516. Epub 2017 Dec 20.
- Loozen CS, van Santvoort HC, van Duijvendijk P, Besselink MG, Gouma DJ, Nieuwenhuijzen GA, Kelder JC, Donkervoort SC, van Geloven AA, Kruyt PM, Roos D, Kortram K, Kornmann VN, Pronk A, van der Peet DL, Crolla RM, van Ramshorst B, Bollen TL, Boerma D. Laparoscopic cholecystectomy versus percutaneous catheter drainage for acute cholecystitis in high risk patients (CHOCOLATE): multicentre randomised clinical trial. BMJ. 2018 Oct 8;363:k3965. doi: 10.1136/bmj.k3965.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SnapChole
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Zapalenie pęcherzyka żółciowego, ostre
-
AmgenJeszcze nie rekrutacjaPhiladelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia