Clinical trial NCT06552949: A Prospective Cohort of Emergent Laparoscopic Cholecystectomy in PUMCH
Official title: Prospective Cohort Study on Emergent Laparoscopic Cholecystectomy Guided by Indocyanine Green (ICG) Fluorescence Versus Conventional Laparoscopic Operation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cholecystitis
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: 2024-08-14
Enrollment: 750
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: incidence of intraoperative accidental bile tract injury
timeFrame: within 1 month
measure: incidence of complications
timeFrame: within 1 month
Secondary outcomes:
measure: intraoperative bleeding (volume)
timeFrame: Intraoperative
measure: duration of postoperative hospital stay
timeFrame: within 1 month
measure: total medical expense
timeFrame: within 1 month
measure: operation time
timeFrame: Intraoperative
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: STUDY_CHAIR
References: