A Prospective Cohort of Emergent Laparoscopic Cholecystectomy in PUMCH

NCT06552949 | Completed DMC

• 1 other identifier: K6454-K24C2458
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective cohort study comparing the surgical outcome of patients who underwent emergent laparoscopic cholecystectomy guided by indocyanine green cholangiography (ELC-ICGC) versus conventional laparoscopic operation. The patients were recruited in the Peking Union Medical Colleg Hospital emergency department from 1st August 2020 to 1st Feburary 2024. A database was prospectively established to collect related data. The surgical outcomes of ELC-ICGC and conventional ElC will be compared.

Conditions

Acute Cholecystitis

Keywords

Emergent laparscopic cholecystectomy; indocyanine green fluorescence; surgical outcome; economic effectiveness; acute cholecystitis

Outcome Measures

Primary Outcomes (2)

• incidence of intraoperative accidental bile tract injury

  The primary outcome is incidence of intraoperative accidental injury involving the bile tract in emergent laparscopic cholecystectomy (ELC) guided by ICG fluorescence. The injury manifests as biliary obstruction, biliary leak, or biliary stricture. Medical records will be reviewed to identify an intraoperative bile tract injury event. Incidence of intraoperative accidental bile tract injury will be collected and comparison between study group (ELC guided by ICG fluorescence) and control group (conventional ELC) will be made

  within 1 month

• incidence of complications

  incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay

  within 1 month

Secondary Outcomes (4)

• intraoperative bleeding (volume)

  Intraoperative

• duration of postoperative hospital stay

  within 1 month

• total medical expense

  within 1 month

• operation time

  Intraoperative

Study Arms (2)

Study group

Patient undergoing emergent laparoscpic cholecystectomy guided by indocyanine green cholangiography (ELC-ICGC)

Procedure: Emergent laparoscopic cholecystectomy guided by ICG cholangiography (ELC-ICGC)

Control group

Patient undergoing emergent conventional laparoscopic cholecystectomy

Interventions

Emergent laparoscopic cholecystectomy guided by ICG cholangiography (ELC-ICGC) PROCEDURE

Emergent conventional laparoscopic cholecystectomy

Study group

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All of the hospitalized patients who underwent ELC by the emergent surgery team from August 1st 2020 to 1st Feburary 2024 in the Department of Emergency in Peking Union Medical College Hospital

You may qualify if:

• Patients underwent ELC performed by the emergent surgeon team Approval to participate

You may not qualify if:

• Patients with incomplete medical records. Patients have other emergent conditions which warrant other emergent operations or major treatment simultaneously besides ELC.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Qiaofei Liu, M.D

  Department of General Surgery, Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate professor

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 14, 2024
• Study Start: August 1, 2020
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)