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

Primary Purpose

Gall Stone, Cholecystitis

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Direct gallbladder injection of ICG intraoperatively
Intravenous injection 2.5 mg
Intravenous injection and direct gallbladder injection
Intravenous injection 5 mg
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gall Stone focused on measuring Cholecystectomy, Flourescent cholangiography

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Indication for laparoscopic cholecystectomy
  • Signed informed consent

Exclusion Criteria:

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

Sites / Locations

  • Østfold Hospital trustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Direct gallbladder injection

2.5 mg intravenously

2.5 mg intravenously + direct gallbladder injection

5 mg intravenously

Arm Description

2.5 mg of ICG will be injected directly into gallbladder intraoperatively.

2.5 mg will ICG will be injected intravenously 1 hour prior to surgery.

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.

5 mg ICG will be injected intravenously 0-8 hours prior to surgery.

Outcomes

Primary Outcome Measures

A questionnaire will be used to evaluate the surgeons experience.
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.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2022
Last Updated
March 28, 2023
Sponsor
Ostfold Hospital Trust
Collaborators
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05376540
Brief Title
Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy
Official Title
Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ostfold Hospital Trust
Collaborators
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gall Stone, Cholecystitis
Keywords
Cholecystectomy, Flourescent cholangiography

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Direct gallbladder injection
Arm Type
Other
Arm Description
2.5 mg of ICG will be injected directly into gallbladder intraoperatively.
Arm Title
2.5 mg intravenously
Arm Type
Other
Arm Description
2.5 mg will ICG will be injected intravenously 1 hour prior to surgery.
Arm Title
2.5 mg intravenously + direct gallbladder injection
Arm Type
Other
Arm Description
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.
Arm Title
5 mg intravenously
Arm Type
Other
Arm Description
5 mg ICG will be injected intravenously 0-8 hours prior to surgery.
Intervention Type
Procedure
Intervention Name(s)
Direct gallbladder injection of ICG intraoperatively
Intervention Description
Patients randomized to this arm will have 2.5 mg ICG injected directly into the gallbladder intraoperatively.
Intervention Type
Procedure
Intervention Name(s)
Intravenous injection 2.5 mg
Intervention Description
Patients randomized to this arm will have 2.5 mg ICG injected intravenously 1 hour prio to surgery
Intervention Type
Procedure
Intervention Name(s)
Intravenous injection and direct gallbladder injection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intravenous injection 5 mg
Intervention Description
Patients randomized to this arm will have 5 mg ICG injected intravenously 0-8 hours prior to surgery
Primary Outcome Measure Information:
Title
A questionnaire will be used to evaluate the surgeons experience.
Description
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.
Time Frame
3-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication for laparoscopic cholecystectomy Signed informed consent Exclusion Criteria: Allergy to indocyanine green or iodine Pregnancy or breast feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carl-Philip Rancinger, MD
Phone
+4769860000
Email
carl-philip.rancinger@so-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Nordby, MD, PhD
Organizational Affiliation
Ostfold Hospital Trust, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Østfold Hospital trust
City
Moss
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl-Philip Rancinger, MD
Phone
+4769860000
Email
carl-philip.rancinger@so-hf.no

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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