Indocyanine Green-Guided Versus Standard Laparoscopic Distal Pancreatectomy for Pancreatic Body and Tail Lesions
Indocyanine Green Fluorescence-Guided Versus Standard Laparoscopic Distal Pancreatectomy: A Prospective Randomized Controlled Trial
Alexandria University
72 participants
Jun 9, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria8
- 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 Criteria9
- 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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Interventions
Laparoscopic distal pancreatectomy for lesions of the pancreatic body and tail, performed with intraoperative indocyanine green (ICG) near-infrared fluorescence imaging at four steps: splenic vessel mapping, splenic perfusion assessment after vessel division (if spleen preservation is intended), pancreatic stump perfusion assessment before transection to guide the resection margin, and fluorescence-guided lymph node mapping in malignant cases
Laparoscopic distal pancreatectomy for pancreatic body and tail lesions performed under white-light visualization without indocyanine green (ICG) fluorescence imaging. Pancreatic transection level, splenic perfusion, and lymphadenectomy are guided solely by the surgeon's conventional assessment
Locations(1)
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NCT07656571