A Prospective Cohort of Emergent Laparoscopic Cholecystectomy in PUMCH (ELC-PUMCH)

Prospective Cohort Study on Emergent Laparoscopic Cholecystectomy Guided by Indocyanine Green (ICG) Fluorescence Versus Conventional Laparoscopic Operation

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.

Study Overview

• Status: Completed
• Conditions: Acute Cholecystitis
• Intervention / Treatment: Procedure: Emergent laparoscopic cholecystectomy guided by ICG cholangiography (ELC-ICGC)

Detailed Description

Acute calculous cholecystitis, typically occurs in patients with gallstones, accounts for 90 to 95% of acute cholecystitis. Emergent laparoscopic cholecystectomy (ELC) is the major treatment option. Traditionally, the time frame for ELC is generally considered to be within 72 hours from the onset of symptoms. However, with the development of surgical techniques, nowadays, ELC is also considered for patients with symptoms onset within 10 days and hospital stays within 7 days. The determination of the time frame for ELC in acute cholecystitis is primarily based on the risk of complications occurring. Comparing to delayed laparoscopic cholecystectomy (DLC), ELC has advantages in post-operative complications in patients with symptoms onset within 72 hours. Post-operative complications for both DLC and ELC include bile leaks, intestinal obstruction, ascites, intraperitoneal hemorrhage, would bleeding and hematoma, wound infection and calculus remaining. Most of them associate with intraoperative procedures. Emergent laparoscopic cholecystectomy guided by indocyanine green (ICG) cholangiography (ELC-ICGC), comparing to conventional LC, potentially can help the surgeons to identify bile tracts and therefore may reduce the complications.

From August 1st 2020, the AC patients undergoing LC in PUMCH were prospecteively registered and a database was established to collect related data.

Till 1st Feburary 2024, about 750 cases of ELC were performed. The surgeons chose to perform either conventional ELC or ELC-ICGC based on their discretion. The patients were followed up within one month after discharge in out patient clinic or telephone interview. We plan to analyze the data from the prospectively established- database.

The surgical outcomes are evaluated by both intraoperative events and postoperative events. Intraoperative events contain the following items: (1) incidence of intraoperative accidental bile tract injury, (2) intraoperative bleeding (volume), (3) operation time. Postoperative events contain the following items: (1) incidence of complications staging 2 and above according to Clavien Dindo Grade during hospital stay, (2) duration of postoperative hospital stay. The economic effectiveness is evaluated by cost of hospital stay.

The surgical outcomes of these two procedures will be compared.

• Study Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Patient undergoing emergent laparoscpic cholecystectomy guided by indocyanine green cholangiography (ELC-ICGC)	Procedure: Emergent laparoscopic cholecystectomy guided by ICG cholangiography (ELC-ICGC); Emergent conventional laparoscopic cholecystectomy
Control group; Patient undergoing emergent conventional laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative bleeding (volume)	Volume of intraoperative bleeding during the operation	Intraoperative
duration of postoperative hospital stay	Days of postoperative hospital stay	within 1 month
total medical expense	Cost during hospital stay	within 1 month
operation time	from cutting the incison to ending the suturing of the incision	Intraoperative

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Qiaofei Liu, M.D, Department of General Surgery, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: acute cholecystitis; surgical outcome; indocyanine green fluorescence; Emergent laparscopic cholecystectomy; economic effectiveness
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: K6454-K24C2458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No