SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis

NCT07568080 | Not Yet Recruiting

• 1 other identifier: SnapChole
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholecystitis, Acute

Keywords

cholecystitis; high-risk; cholecystectomy; percutaneous cholecystostomy; target trial emulation

Outcome Measures

Primary Outcomes (1)

• Days alive and out of hospital at 90 days

  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)

Secondary Outcomes (5)

• All-cause mortality

  90 days from time zero

• Failure of Source Control

  Within 90 days from time zero

• Unplanned biliary reintervention

  within 90 days of time zero

• Length of hospital stay

  From hospital admission to hospital discharge, assessed up to 90 days from time zero

• Time to achieved source control

  From time zero to completion of source-control intervention, assessed up to 90 days

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with severe acute calculous cholecystitis (Tokyo Guidelines 2018 Grade III) presenting to participating centers and managed under routine clinical care. The population reflects patients in whom treatment decisions are influenced by physiologic severity, comorbidity, and institutional capability. Consecutive eligible patients are enrolled prospectively to define a real-world denominator cohort. Analytic subsets are subsequently defined at the attending surgeon-level decision point to evaluate treatment strategies under conditions in which alternative approaches are simultaneously feasible.

You may qualify if:

• 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

You may not qualify if:

• Acalculous cholecystitis
• Isolated choledocholithiasis or acute cholangitis without cholecystitis
• Primary gallstone pancreatitis without concomitant acute cholecystitis
• Elective admission for chronic biliary symptoms
• Prior cholecystectomy

Sponsors & Collaborators

• European Society for Trauma and Emergency Surgery: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (6)

• 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.

  PMID: 35840703 BACKGROUND

• 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.

  PMID: 30297544 BACKGROUND

• 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.

  PMID: 26994063 BACKGROUND

• 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.

  PMID: 33153472 BACKGROUND

• 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.

  PMID: 29045062 BACKGROUND

• 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.

  PMID: 29032636 BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute; Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Gary A Bass, MD, PhD

  University of Pennsylvania

  STUDY CHAIR

Central Study Contacts

Gary A Bass, MD, PhD

CONTACT

2672168309; gary.bass@pennmedicine.upenn.edu

Stefano PB Cioffi, MD, PhD

CONTACT

2672168309; stefanopiero.cioffi@ospedaleniguarda.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)