Gall StoneNCT05376540
Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy
A study testing Direct gallbladder injection of ICG intraoperatively, Intravenous injection 2.5 mg and Intravenous injection and direct gallbladder injection in people with Gall Stone and Cholecystitis, run by Ostfold Hospital Trust at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Gall Stone, Cholecystitis
- What is being tested?
- Direct gallbladder injection of ICG intraoperatively, Intravenous injection 2.5 mg and Intravenous injection and direct gallbladder injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 3 Mar 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for laparoscopic cholecystectomy
- Signed informed consent
Who cannot join
- Allergy to indocyanine green or iodine
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Østfold Hospital trust
Moss
Carl-Philip Rancinger, MD, +4769860000, carl-philip.rancinger@so-hf.no
About this study
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.
- Conditions
- Gall Stone, Cholecystitis
- Being tested
- Direct gallbladder injection of ICG intraoperatively, Intravenous injection 2.5 mg, Intravenous injection and direct gallbladder injection, Intravenous injection 5 mg
- Keywords
- Cholecystectomy, Flourescent cholangiography
- Medical subject headings
- Gallstones, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct gallbladder injection of ICG intraoperativelyProcedure or surgery
Patients randomized to this arm will have 2.5 mg ICG injected directly into the gallbladder intraoperatively.
Intravenous injection 2.5 mgProcedure or surgery
Patients randomized to this arm will have 2.5 mg ICG injected intravenously 1 hour prio to surgery
Intravenous injection and direct gallbladder injectionProcedure or surgery
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.
Intravenous injection 5 mgProcedure or surgery
Patients randomized to this arm will have 5 mg ICG injected intravenously 0-8 hours prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Direct gallbladder injection | Other | 2.5 mg of ICG will be injected directly into gallbladder intraoperatively. Receives: Procedure: Direct gallbladder injection of ICG intraoperatively |
| 2.5 mg intravenously | Other | 2.5 mg will ICG will be injected intravenously 1 hour prior to surgery. Receives: Procedure: Intravenous injection 2.5 mg |
| 2.5 mg intravenously + direct gallbladder injection | Other | 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. Receives: Procedure: Intravenous injection and direct gallbladder injection |
| 5 mg intravenously | Other | 5 mg ICG will be injected intravenously 0-8 hours prior to surgery. Receives: Procedure: Intravenous injection 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start3 Mar 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gall StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Tom Nordby, MD, PhD, Principal investigator, Ostfold Hospital Trust, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376540
- Sponsor's protocol ID
- REK280193
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy
- ClinicalTrials.gov ID
- NCT05376540
- Acronym / sponsor ID
- REK280193
- Conditions
- Gall Stone, Cholecystitis
- Keywords
- Cholecystectomy, Flourescent cholangiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Direct gallbladder injection | Other | Procedure: Direct gallbladder injection of ICG intraoperatively2.5 mg of ICG will be injected directly into gallbladder intraoperatively. |
| 2.5 mg intravenously | Other | Procedure: Intravenous injection 2.5 mg2.5 mg will ICG will be injected intravenously 1 hour prior to surgery. |
| 2.5 mg intravenously + direct gallbladder injection | Other | Procedure: Intravenous injection and direct gallbladder injection2.5 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 intravenously | Other | Procedure: Intravenous injection 5 mg5 mg ICG will be injected intravenously 0-8 hours prior to surgery. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for laparoscopic cholecystectomy
- Signed informed consent
Key exclusion criteria (2 listed)
- Allergy to indocyanine green or iodine
- Pregnancy or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct gallbladder injection of ICG intraoperativelyPatients randomized to this arm will have 2.5 mg ICG injected directly into the gallbladder intraoperatively. | Procedure or surgery | Direct gallbladder injection |
| Intravenous injection 2.5 mgPatients randomized to this arm will have 2.5 mg ICG injected intravenously 1 hour prio to surgery | Procedure or surgery | 2.5 mg intravenously |
| Intravenous injection and direct gallbladder injectionPatients 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. | Procedure or surgery | 2.5 mg intravenously + direct gallbladder injection |
| Intravenous injection 5 mgPatients randomized to this arm will have 5 mg ICG injected intravenously 0-8 hours prior to surgery | Procedure or surgery | 5 mg intravenously |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Nordby, MD, PhD principal investigator
Ostfold Hospital Trust, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct gallbladder injection of ICG intraoperatively, Intravenous injection 2.5 mg and Intravenous injection and direct gallbladder injection in people with Gall Stone and Cholecystitis, run by Ostfold Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carl-Philip Rancinger, MD (+4769860000, carl-philip.rancinger@so-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A questionnaire will be used to evaluate the surgeons experience. (time frame: 3-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.