Clinical trial NCT06549881: Emergent Laparoscopic Cholecystectomy With ICG Cholangiography
Official title: Emergency Laparoscopic Cholecystectomy Guided by Indocyanine Green (ICG) Fluorescence: a Single Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cholestatic Hepatitis
Keywords: Emergent laparscopic cholecystectomy
indocyanine green fluorescence
surgical outcome
economic effectiveness
acute cholecystitis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute cholecystitis warrant emergent laparscopic cholecystectomy.

Brief summary: A consecutive case series report to share our experience in surgical outcome of patients who underwent emergency laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence. The patients were recruited in PUMCH emergency department from 2023 to 2024.

Detailed description: Acute calculous cholecystitis, typically occurs in patients with gallstones, accounts for 90 to 95% of acute cholecystitis. Emergent laparscopic 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 laparscopic 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. Laparoscopic cholecystectomy guided by indocyanine green (ICG) fluorescence, comparing to conventional laparscopic procedures, can help the surgeons to identify bile tracts and therefore may reduce the complications. Therefore, we conduct this case series report to share our single center experience of surgical outcomes and economic effectiveness of laparoscopic cholecystectomy guided by ICG.

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.

Eligibility criteria: Inclusion Criteria:

* All of the hospitalized patients of underwent emergent laparscopic cholecystectomy guided by ICG fluorescence by the emergent surgeon team from 1st August 2023 to 1st Feburary 2024 in the department of Emergency in Peking Union Medical College Hospital

Exclusion Criteria:

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

Primary outcomes:
measure: incidence of intraoperative accidental bile tract injury
timeFrame: within 1 month after after discharge
measure: incidence of postoperative complications
timeFrame: within 1 month after discharge
Secondary outcomes:
measure: duration of postoperative hospital stay
timeFrame: within 1 month after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Department of General Surgery, Peking Union Medical College Hospital
name: Qiaofei Liu, M.D
role: PRINCIPAL_INVESTIGATOR
References: