Fluorescent Dye Guidance During Keyhole Surgery for Pancreatic Body and Tail Tumors

Trial details

Who runs it

Alexandria University

Trial code

NCT07656571

Record updated

18 June 2026

Original description

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.Read full original descriptionShow less

Indocyanine Green Fluorescence-Guided Versus Standard Laparoscopic Distal Pancreatectomy: A Prospective Randomized Controlled 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.

Inclusion: 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: Prior major upper abdominal surgery precluding safe laparoscopic access (for example previous pancreatectomy or gastrectomy) as judged by the surgeon; Concurrent participation in another interventional clinical trial; Known allergy or hypersensitivity to indocyanine green (ICG), iodine, or iodinated contrast agents; Presence of distant metastases or locally advanced disease requiring vascular resection at the time of surgery; Severe hepatic impairment (Child-Pugh class C); Uncorrected coagulopathy (international normalized ratio > 1.5 or platelet count < 80 × 10⁹/L); Pregnancy or breastfeeding; American Society of Anesthesiologists (ASA) physical status classification IV or V; Inability or unwillingness to comply with scheduled follow-up visits and assessments.

ClinicalTrials.gov NCT07656571