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Use of Indocyanine Green in Acute Cholecystitis (INDURG)

Primary Purpose

Acute Cholecystitis, Bile Duct Injury

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Indocyanine green
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Cholecystitis focused on measuring Indocyanine green

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with an indication for urgent laparoscopic cholecystectomy due to acute cholecystitis regardless of its etiology. Age over 18 years. Patients who have read the study information sheet and signed the informed consent sheet. Exclusion Criteria: Pregnant or breastfeeding patients. Grade IV renal failure or patients on dialysis Patients with previous hypersensitivity to indocyanine green Patients with allergy to iodinated contrast Patients with clinical hyperthyroidism, autonomic thyroid adenomas, and focal and diffuse autonomic abnormalities of the thyroid gland Contraindication to laparoscopic surgery. Suspicion of choledocholithiasis Pediatric patients under 18 years of age. Patients who refused to participate in the study

Sites / Locations

  • Hospital Universitari Parc TauliRecruiting
  • Hospital de VicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control group

intervention group

Arm Description

patients who undergo urgent laparoscopic cholecystectomy according to the usual technique without the administration of indocyanine green

Patients who undergo urgent laparoscopic cholecystectomy for acute cholecystitis with the administration of indocyanine green preoperatively.

Outcomes

Primary Outcome Measures

operating time
time between the start of the surgical incision and the end of surgery

Secondary Outcome Measures

admission days
days of hospital admission
intraoperative complications
surgical injuries during surgery
postoperative morbidity
complications evidenced in the postoperative period
visualization of biliary anatomy with indocyanine green
Evidence the correct visualization of the biliary structures after the administration of indocyanine green

Full Information

First Posted
January 12, 2023
Last Updated
September 27, 2023
Sponsor
Corporacion Parc Tauli
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1. Study Identification

Unique Protocol Identification Number
NCT05709548
Brief Title
Use of Indocyanine Green in Acute Cholecystitis
Acronym
INDURG
Official Title
INDURG TRIAL: A Randomized Controlled Trial Using Indocyanine Green During Cholecystectomy in Acute Cholecystitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Laparoscopic cholecystectomy is one of the most common gastrointestinal surgeries. However, it can be technically complex in those patients diagnosed with acute cholecystitis who present severe inflammation or fibrosis, with bile duct injury being one of its main complications. The use of fluorescence cholangiography through the use of indocyanine green allows the identification of extrahepatic biliary structures, facilitating dissection and reducing the risk of bile duct lesions. Better visualization of the bile duct allows reducing the conversion rate to open surgery, as well as operating time. The main objective is to assess a decrease in operating time in acute cholecystitis undergoing emergency surgery, to which indocyanine green is administered preoperatively. Randomized, prospective, controlled, multicenter clinical trial of two groups of patients diagnosed with acute cholecystitis and requiring urgent cholecystectomy. The control group includes 220 patients who undergo urgent laparoscopic cholecystectomy according to the usual technique without the administration of indocyanine green, and the intervention group includes 220 patients who undergo urgent laparoscopic cholecystectomy for acute cholecystitis with the administration of indocyanine green preoperatively. Study led by the Parc Taulí University Hospital in Sabadell.
Detailed Description
Prospective, controlled, randomized and multicenter clinical trial comparing conventional laparoscopic cholecystectomy versus laparoscopic cholecystectomy with preoperative indocyanine green administration in patients with an indication for urgent cholecystectomy due to acute cholecystitis (of any etiology), at the Parc Taulí University Hospital and at the Germans Trias i Pujol University Hospital. Parallel group randomization (1:1) will be performed by opening sealed envelopes, with random assignment between the two groups (intervention and control). The same number of envelopes will be assigned to the study and control group, all of them sealed and placed at random. A four-port laparoscopic cholecystectomy will be performed by a team of surgeons with extensive experience in emergency and/or hepatobiliopancreatic surgery, according to standard techniques and safety measures. Randomization will be carried out at the time of the indication for surgery, after acceptance and signing of the informed consent once all the inclusion criteria are met.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis, Bile Duct Injury
Keywords
Indocyanine green

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
patients who undergo urgent laparoscopic cholecystectomy according to the usual technique without the administration of indocyanine green
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
Patients who undergo urgent laparoscopic cholecystectomy for acute cholecystitis with the administration of indocyanine green preoperatively.
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Other Intervention Name(s)
indocyanine green group
Intervention Description
Subjects with a diagnosis of acute cholecystitis who undergo urgent laparoscopic cholecystectomy with the preoperative administration of indocyanine green (between 1-2 hours prior to surgery).
Primary Outcome Measure Information:
Title
operating time
Description
time between the start of the surgical incision and the end of surgery
Time Frame
from the beginning of the surgery to its end, up to 300 minutes
Secondary Outcome Measure Information:
Title
admission days
Description
days of hospital admission
Time Frame
length of hospital stay, from admission to discharge, up to 3 month
Title
intraoperative complications
Description
surgical injuries during surgery
Time Frame
during surgical time
Title
postoperative morbidity
Description
complications evidenced in the postoperative period
Time Frame
in the first 30 days after surgery
Title
visualization of biliary anatomy with indocyanine green
Description
Evidence the correct visualization of the biliary structures after the administration of indocyanine green
Time Frame
during surgical time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with an indication for urgent laparoscopic cholecystectomy due to acute cholecystitis regardless of its etiology. Age over 18 years. Patients who have read the study information sheet and signed the informed consent sheet. Exclusion Criteria: Pregnant or breastfeeding patients. Grade IV renal failure or patients on dialysis Patients with previous hypersensitivity to indocyanine green Patients with allergy to iodinated contrast Patients with clinical hyperthyroidism, autonomic thyroid adenomas, and focal and diffuse autonomic abnormalities of the thyroid gland Contraindication to laparoscopic surgery. Suspicion of choledocholithiasis Pediatric patients under 18 years of age. Patients who refused to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Muñoz Campaña, PhD
Phone
003493 723 10 10
Ext
80614
Email
amunozc@tauli.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Coloma Moreno
Phone
003493 723 10 10
Ext
22219
Email
cmoreno@tauli.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Muñoz Campaña, PhD
Organizational Affiliation
Hospital Universitari Parc Taulí
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enrico Marrano
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANNA MUÑOZ-CAMPAÑA, PhD
Phone
003493 723 10 10
Ext
80614
Email
amunozc@tauli.cat
First Name & Middle Initial & Last Name & Degree
ENRICO MARRANO
Phone
0034934 65 12 00
Email
enrico.marrano@gmail.com
Facility Name
Hospital de Vic
City
Vic
State/Province
Barcelona
ZIP/Postal Code
. 08500
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VICTORIA LUCAS GUERRERO, Dr
Email
victorialucasg@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34629815
Citation
Pesce A, Piccolo G, Lecchi F, Fabbri N, Diana M, Feo CV. Fluorescent cholangiography: An up-to-date overview twelve years after the first clinical application. World J Gastroenterol. 2021 Sep 28;27(36):5989-6003. doi: 10.3748/wjg.v27.i36.5989.
Results Reference
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PubMed Identifier
32936054
Citation
Di Maggio F, Hossain N, De Zanna A, Husain D, Bonomo L. Near-Infrared Fluorescence Cholangiography can be a Useful Adjunct during Emergency Cholecystectomies. Surg Innov. 2022 Aug;29(4):526-531. doi: 10.1177/1553350620958562. Epub 2020 Sep 16.
Results Reference
background
PubMed Identifier
34952715
Citation
Reeves JJ, Broderick RC, Lee AM, Blitzer RR, Waterman RS, Cheverie JN, Jacobsen GR, Sandler BJ, Bouvet M, Doucet J, Murphy JD, Horgan S. The price is right: Routine fluorescent cholangiography during laparoscopic cholecystectomy. Surgery. 2022 May;171(5):1168-1176. doi: 10.1016/j.surg.2021.09.027. Epub 2021 Dec 21.
Results Reference
background
PubMed Identifier
30614881
Citation
Dip F, LoMenzo E, Sarotto L, Phillips E, Todeschini H, Nahmod M, Alle L, Schneider S, Kaja L, Boni L, Ferraina P, Carus T, Kokudo N, Ishizawa T, Walsh M, Simpfendorfer C, Mayank R, White K, Rosenthal RJ. Randomized Trial of Near-infrared Incisionless Fluorescent Cholangiography. Ann Surg. 2019 Dec;270(6):992-999. doi: 10.1097/SLA.0000000000003178.
Results Reference
background
PubMed Identifier
33351457
Citation
Wang X, Teh CSC, Ishizawa T, Aoki T, Cavallucci D, Lee SY, Panganiban KM, Perini MV, Shah SR, Wang H, Xu Y, Suh KS, Kokudo N. Consensus Guidelines for the Use of Fluorescence Imaging in Hepatobiliary Surgery. Ann Surg. 2021 Jul 1;274(1):97-106. doi: 10.1097/SLA.0000000000004718.
Results Reference
background
PubMed Identifier
33052527
Citation
Broderick RC, Lee AM, Cheverie JN, Zhao B, Blitzer RR, Patel RJ, Soltero S, Sandler BJ, Jacobsen GR, Doucet JJ, Horgan S. Fluorescent cholangiography significantly improves patient outcomes for laparoscopic cholecystectomy. Surg Endosc. 2021 Oct;35(10):5729-5739. doi: 10.1007/s00464-020-08045-x. Epub 2020 Oct 14.
Results Reference
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PubMed Identifier
27566635
Citation
van den Bos J, Schols RM, Luyer MD, van Dam RM, Vahrmeijer AL, Meijerink WJ, Gobardhan PD, van Dam GM, Bouvy ND, Stassen LP. Near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy (FALCON trial): study protocol for a multicentre randomised controlled trial. BMJ Open. 2016 Aug 26;6(8):e011668. doi: 10.1136/bmjopen-2016-011668.
Results Reference
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PubMed Identifier
35241165
Citation
Pavel MC, Boira MA, Bashir Y, Memba R, Llacer E, Estalella L, Julia E, Conlon KC, Jorba R. Near infrared indocyanine green fluorescent cholangiography versus intraoperative cholangiography to improve safety in laparoscopic cholecystectomy for gallstone disease-a systematic review protocol. Syst Rev. 2022 Mar 3;11(1):36. doi: 10.1186/s13643-022-01907-6.
Results Reference
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Use of Indocyanine Green in Acute Cholecystitis

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