Glowing dye may make pancreatic surgery safer
NCT ID NCT07656571
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial compares two types of keyhole surgery to remove the tail of the pancreas. One uses a dye called indocyanine green that glows under special lights, helping surgeons see blood flow and decide where to cut. The other is the standard procedure without the dye. The goal is to see if the dye reduces the risk of a pancreatic fistula, a common and serious leak of digestive fluids. Adults needing this surgery for tumors in the body or tail of the pancreas may join.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- indocyanine green (ICG) dye
- What this could lead to
- If it works, this could make laparoscopic pancreatic surgery safer by reducing the risk of a serious complication called pancreatic fistula.
- What could go wrong
- This is a relatively small, early-stage trial, so results may not apply to all patients. The dye may not improve outcomes, and there are always risks from surgery itself.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years. * Body mass index (BMI) ≤ 40 kg/m². * Radiologically confirmed lesion(s) of the pancreatic body and/or tail requiring elective distal pancreatectomy, with or without splenectomy. * Lesion amenable to a laparoscopic approach as determined by the operating surgeon on preoperative CT or MRI imaging. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Adequate hepatic function: serum bilirubin ≤ 2 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN. * Patients who have received neoadjuvant chemotherapy, chemoradiotherapy, or radiotherapy are eligible if resectability is confirmed on restaging imaging and at least 3 weeks have elapsed since the last treatment dose. * Ability to provide written informed consent and willingness to comply with study follow-up. Exclusion Criteria: * Known allergy or hypersensitivity to indocyanine green (ICG), iodine, or iodinated contrast agents. * Uncorrected coagulopathy (international normalized ratio \> 1.5 or platelet count \< 80 × 10⁹/L). * Pregnancy or breastfeeding. * Prior major upper abdominal surgery precluding safe laparoscopic access (for example previous pancreatectomy or gastrectomy) as judged by the surgeon. * Presence of distant metastases or locally advanced disease requiring vascular resection at the time of surgery. * American Society of Anesthesiologists (ASA) physical status classification IV or V. * Severe hepatic impairment (Child-Pugh class C). * Inability or unwillingness to comply with scheduled follow-up visits and assessments. * Concurrent participation in another interventional clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Faculty of Medicine, Alexandria University
RECRUITINGAlexandria, Egypt
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