Indocyanine Green Imaging for Bariatric Surgery

Overseen by Allan Okrainec

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University Health Network, Toronto

Disqualifiers: Pregnancy, Substance abuse, Smoking, others

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a special imaging technique with a dye to help doctors see blood flow during gastric bypass surgery. It aims to reduce complications like ulcers and leaks by ensuring good blood flow at surgical connections. The study focuses on patients having this type of weight-loss surgery.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be willing to take PPI medication (a type of drug that reduces stomach acid) after the surgery.

What data supports the effectiveness of the treatment Indocyanine Green (ICG) Imaging for Bariatric Surgery?

Indocyanine Green (ICG) is a dye that helps doctors see how well blood is flowing to tissues during surgery, which can help reduce complications like leaks. Studies show that using ICG during bariatric surgery can lead to changes in surgical decisions in about 3.8% of cases, suggesting it may help improve outcomes. ^{1 2 3 4 5}

Is Indocyanine Green (ICG) safe for use in humans?

Indocyanine Green (ICG) has been used safely for over 30 years in various medical tests, including those for heart and liver function, with a high level of safety. Although adverse reactions can occur, they are generally rare, and ICG is considered safe for use in humans. ^{2 3 4 5 6}

How does indocyanine green imaging differ from other treatments in bariatric surgery?

Indocyanine green imaging is unique because it uses a fluorescent dye to assess blood flow and tissue health during bariatric surgery, helping to reduce complications like leaks by providing real-time visualization, unlike traditional methods that rely on less precise evaluations. ^{2 3 4 5 7}

Research Team

Allan Okrainec

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for adults over 18 who are eligible for Roux-en-Y gastric bypass (RYGB) surgery in Ontario and can commit to the bariatric program's follow-up, including lifestyle changes. They must be able to consent and may have had treatment for a marginal ulcer. It excludes those with allergies to indocyanine green or Sodium Iodide, substance abuse/smoking issues, unwillingness to take PPIs post-op, pregnancy plans within two years, or bleeding/coagulation disorders.

Inclusion Criteria

I am committed to following the bariatric program's guidelines for diet and behavior changes.

I understand and can agree to the study's procedures and risks.

I am over 18 years old.

Exclusion Criteria

Known allergy to indocyanine green or Sodium Iodide

Is participant pregnant or planning to get pregnant in next two years

Ongoing substance abuse or active smoking

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

ICG imaging is performed intraoperatively to assess blood flow during Roux-en-Y gastric bypass surgery

1 day

1 visit (in-person, surgery)

Follow-up

Participants are monitored for complications such as marginal ulcerations, leaks, and strictures

2 years

Standard bariatric follow-up visits

Mid-term analysis

Mid-term analysis of procedure and patient outcomes for quality assurance

When half the study patients have undergone intraoperative ICG use

Treatment Details

Interventions

• Indocyanine Green (Other)

Trial Overview The study tests if using the Stryker 1688 AIM system along with Indocyanine Green dye helps surgeons see blood flow during RYGB surgery better. The goal is to check if this method reduces complications like ulcers, leaks, and strictures after surgery.

Participant Groups

Group I: Interventional group (with drug) Experimental Treatment 2 Interventions

The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

Stryker Endoscopy

Industry Sponsor

Trials

5

Recruited

2,000+

Findings from Research

In a study of 30 patients undergoing laparoscopic Roux-en-Y Gastric Bypass, indocyanine green (ICG) fluorescence angiography effectively demonstrated adequate blood supply to the stomach and gastro-jejunal anastomosis during surgery.

Despite showing good perfusion with ICG, the methylene blue test indicated potential risks for leakage, suggesting that while ICG can help assess vascularity, other factors also contribute to the risk of gastric fistula formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anastomotic leak test using indocyanine green during laparoscopic Roux-en-Y gastric bypass: A cohort study. Pavone, G., Fersini, A., Pacilli, M., et al.[2022]

Indocyanine green (ICG) is a useful fluorescent dye in bariatric surgery that can help assess tissue perfusion and perform leak testing, potentially leading to intraoperative decision changes in 3.8% of cases.

The study highlights the need for further research to confirm the routine use of ICG in both standard and complex bariatric surgical procedures, indicating its promise in reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine Green in Bariatric Surgery: a Systematic Review. Hsu, A., Mu, SZ., James, A., et al.[2023]

In a pilot study involving 13 bariatric surgery patients, the use of indocyanine green (ICG) fluorescence angiography (FA) was found to be safe and effective, with no adverse effects reported and 84.6% of patients showing excellent vascularization scores.

The ICG-FA helped identify vascular supply issues in two patients, leading to changes in surgical strategy, and importantly, no postoperative leaks occurred during a median follow-up of five months, suggesting its potential to reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine Green Fluorescence Angiography During Laparoscopic Bariatric Surgery: A Pilot Study. Balla, A., Corallino, D., Quaresima, S., et al.[2022]

In a study of 43 patients undergoing laparoscopic sleeve gastrectomy, the use of indocyanine green (ICG) for assessing blood supply showed no adverse events, indicating its safety in this context.

Despite satisfactory blood supply assessments along the stapled line in all cases, one patient experienced a gastric leak post-surgery, suggesting that blood supply alone may not predict leak risk, highlighting the need for further investigation into other contributing factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine Green Fluorescent Angiography During Laparoscopic Sleeve Gastrectomy: Preliminary Results. Di Furia, M., Romano, L., Salvatorelli, A., et al.[2021]

In a study involving 40 bariatric surgery patients, the use of quantitative indocyanine green fluorescence angiography (ICG-FA) showed no adverse events and effectively assessed blood supply during surgery.

Importantly, there were no post-operative leaks detected in any of the patients, suggesting that ICG-FA could be a valuable tool for preventing complications in bariatric surgery, although more research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of quantitative indocyanine green near-infrared fluorescence imaging in bariatric surgery: early results. Biancucci, A., Fassari, A., Lucchese, S., et al.[2023]

In a study involving 1226 patients and 1923 ICG videoangiography tests, the safety of intravenous indocyanine green (ICG) was confirmed, with only 0.15% experiencing mild adverse reactions and 0.2% moderate reactions.

The study found one severe adverse reaction (0.05%) but no fatalities, highlighting the high level of safety associated with ICG in ophthalmic imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse reactions due to indocyanine green. Hope-Ross, M., Yannuzzi, LA., Gragoudas, ES., et al.[2022]

In a study of 266 patients with gastric cancer, the use of indocyanine green (ICG) imaging during laparoscopic D2 lymphadenectomy significantly increased the number of lymph nodes retrieved compared to conventional methods, with an average of 50.5 lymph nodes in the ICG group versus 42.0 in the non-ICG group.

The ICG group also had a lower rate of lymph node noncompliance (31.8%) compared to the non-ICG group (57.4%), while the postoperative recovery and complication rates were similar between both groups, indicating that ICG imaging is safe and effective for enhancing lymphatic mapping in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial. Chen, QY., Xie, JW., Zhong, Q., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Anastomotic leak test using indocyanine green during laparoscopic Roux-en-Y gastric bypass: A cohort study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Indocyanine Green in Bariatric Surgery: a Systematic Review. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Indocyanine Green Fluorescence Angiography During Laparoscopic Bariatric Surgery: A Pilot Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Indocyanine Green Fluorescent Angiography During Laparoscopic Sleeve Gastrectomy: Preliminary Results. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Use of quantitative indocyanine green near-infrared fluorescence imaging in bariatric surgery: early results. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse reactions due to indocyanine green. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial. [2020]