SnapChole

Management strategies and outcomes in acute calculous cholecystitis.

SnapChole banner graphic

SnapChole is an international, time-bound prospective platform study of acute calculous cholecystitis that characterizes pathway selection, source-control strategy, and 90-day outcomes under real-world emergency surgical conditions. In severe disease, the platform embeds prespecified target trial emulations so competing strategies can be compared from a clearly defined decision point rather than after treatment pathways diverge.

Last updated: 2026-05-04 Protocol v1.0 · 2026-04-26 ClinicalTrials.gov: NCT07568080

Leadership and governance

Study coordination and collaborative structure.

Gary Alan Bass

Principal Investigator

Gary Alan Bass, MD, MSc, MBA, PhD, FICS, FEBS (Emergency Surgery)
Assistant Professor of Surgery and Assistant Professor of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania
gary.bass@pennmedicine.upenn.edu

Steering group

Lewis J. Kaplan, Matthew J. Lee, Nandita Mitra, Dane Isenberg, Hayato Kurihara, and Isidro Martínez-Casas contribute scientific, statistical, and multicenter oversight.

Society collaboration

SnapChole is conducted with ESTES, ASGBI, SIS-NA, and SIS-E collaboration to support international participation.

Why this study exists

Variation in severe cholecystitis remains analytically difficult.

Acute calculous cholecystitis is common, but severe disease is where strategy selection becomes most consequential. Patients may be assigned to early cholecystectomy, drainage-first, or antimicrobial-only management under superficially similar decision contexts, yet those decisions are shaped by physiologic reserve, reversibility of organ dysfunction, diagnostic certainty, and system capability.

SnapChole addresses that problem. The study does not treat pathway selection as a retrospective coding exercise. It captures the attending surgeon–level decision point as time zero and preserves the variables needed to estimate the effect of source-control strategies in clinically coherent populations.

Primary outcome

DAOH90

Days alive and out of hospital at 90 days

Time zero

Decision point

The first attending surgeon–level decision at which competing strategies are feasible

Strategy 1

Early cholecystectomy vs drainage-first

Strategy 2

Drainage-first vs antimicrobial-only

Design

What SnapChole measures.

Platform cohort

International multicenter prospective enrollment using a predefined 90-day local accrual window with standardized contemporaneous data capture.

Severe disease focus

The target trial emulations are restricted to adults with Tokyo Guidelines 2018 Grade III acute calculous cholecystitis in whom competing strategies are simultaneously feasible.

Design-first causal framework

Eligibility, assignment, time zero, grace period, follow-up, and estimands are specified before analysis to reduce immortal time bias and post-baseline selection.

Complementary work packages

Beyond the core causal analyses, the platform supports benchmarking, PROMs, surgeon decision-making work, and implementation-oriented pathway development.

Nested target trial emulations

Two prespecified causal comparisons.

TTE1

Early cholecystectomy vs drainage-first

  • Population: adults with TG18 Grade III disease eligible for both strategies at time zero
  • Assignment: predefined source-control pathway
  • Adherence: completion within a 24-hour grace period, with 12-hour sensitivity analysis
  • Estimand: per-protocol effect of assignment to a strategy achieving completed source control within the grace period

TTE2

Drainage-first vs antimicrobial-only management

  • Population: patients not selected for immediate surgery but eligible for both temporizing strategies
  • Assignment: drainage-first pathway vs antimicrobial-only pathway
  • Outcome framework: same 90-day follow-up with DAOH90 as the primary outcome
  • Analysis: cloning, censoring, inverse probability weighting, and doubly robust estimation

Implementation is part of the design. The platform is intended not only to produce interpretable estimates, but to translate them into a decision-aligned clinical pathway and implementation toolkit for routine emergency surgical workflows.

Additional work packages include patient-reported outcomes, surgeon decision-making under uncertainty, and contextual analysis of institutional constraints that shape pathway assignment in real practice.

SnapChole rationale figure

For participating centers and collaborators

How to engage with the study.

SnapChole is for centers able to support consecutive prospective case ascertainment, standardized data collection, and protocol-aligned follow-up using routine clinical data. Methodologic collaborators, analysts, and implementation scientists are considered through CESOR participation pathways.

For participating centers

Site interest and onboarding

Centers interested in participation should contact the study leadership and submit structured intake through CESOR.

For analysts and collaborators

Methods, implementation, and secondary analyses

Collaborators with relevant methodological, statistical, implementation, or emergency surgery expertise should review CESOR participation pathways before initial outreach.