Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy

March 28, 2023 updated by: Ostfold Hospital Trust
The purpose of this study is to compare different dosages and ways of administration of indocyanine green during fluorescent cholangiography in laparoscopic cholecystectomy. The study is randomized.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication for laparoscopic cholecystectomy
  • Signed informed consent

Exclusion Criteria:

  • Allergy to indocyanine green or iodine
  • Pregnancy or breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Direct gallbladder injection
2.5 mg of ICG will be injected directly into gallbladder intraoperatively.
Procedure: Direct gallbladder injection of ICG intraoperatively
Patients randomized to this arm will have 2.5 mg ICG injected directly into the gallbladder intraoperatively.
Other: 2.5 mg intravenously
2.5 mg will ICG will be injected intravenously 1 hour prior to surgery.
Procedure: Intravenous injection 2.5 mg
Patients randomized to this arm will have 2.5 mg ICG injected intravenously 1 hour prio to surgery
Other: 2.5 mg intravenously + direct gallbladder injection
2.5 mg ICG will be injected intravenously 1 hour prior to surgery and another 2.5 mg ICG will be injected directly into the gallbladder intraoperatively.
Procedure: Intravenous injection and direct gallbladder injection
Patients randomized to this arm will have 2.5 mg ICG injected intravenously 1 hour prior to surgery and another 2.5 mg ICG injected directly into the gallbladder, intraoperatively.
Other: 5 mg intravenously
5 mg ICG will be injected intravenously 0-8 hours prior to surgery.
Procedure: Intravenous injection 5 mg
Patients randomized to this arm will have 5 mg ICG injected intravenously 0-8 hours prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A questionnaire will be used to evaluate the surgeons experience.
Time Frame: 3-4 months
This study aims to compare the surgeons subjective experience of ICG utility for different dosages and route of administration of indocyanine green in patients operated with laparoscopic cholecystectomy. A questionnaire will be used to evaluate the surgeons experience.
3-4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ostfold Hospital Trust

Collaborators

Oslo University Hospital

Investigators

  • Principal Investigator: Tom Nordby, MD, PhD, Ostfold Hospital Trust, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK280193

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholecystitis

Clinical Trials on Direct gallbladder injection of ICG intraoperatively

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe