Indocyanine Green-Guided Versus Standard Laparoscopic Distal Pancreatectomy for Pancreatic Body and Tail Lesions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexandria University

About this trial

Postoperative pancreatic fistula is the most important complication after laparoscopic distal pancreatectomy for tumors of the body and tail of the pancreas. It can cause infection, bleeding, longer hospital stay, and even death. New imaging technology using indocyanine green (ICG) dye and near-infrared fluorescence may help surgeons see blood flow to the pancreatic stump, spleen, and nearby vessels during surgery and make safer decisions about where to cut and which structures to preserve.

This study will compare two standard laparoscopic operations for pancreatic body and tail lesions: one with ICG fluorescence imaging at key steps of the procedure and one without ICG imaging. Adult patients who need elective laparoscopic distal pancreatectomy will be randomly assigned to one of the two groups. All other aspects of care before, during, and after surgery will be the same.

The main goal is to find out whether using ICG fluorescence can reduce the rate of clinically relevant postoperative pancreatic fistula (Grade B or C) within 90 days after surgery. Secondary goals include comparing blood loss, operating time, need to convert to open surgery, spleen preservation, complications, hospital stay, and oncologic outcomes such as margin status and lymph node yield.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ICG Fluorescence-Guided Laparoscopic Distal Pancreatectomy
  • Standard Laparoscopic Distal Pancreatectomy

Treatment groups

72 Participants
are divided into 2 treatment groups

Locations

1
Faculty of Medicine, Alexandria University Alexandria Egypt

Sponsors and collaborators

Alexandria University

Lead sponsor