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

Laparoscopic distal pancreatectomy is now widely used for lesions of the pancreatic body and tail, but postoperative pancreatic fistula (POPF) remains a frequent and serious problem. POPF is associated with prolonged hospital stay, sepsis, post-pancreatectomy hemorrhage, and higher perioperative mortality. Current methods for choosing the pancreatic transection line and judging stump and splenic perfusion rely mainly on the surgeon's visual assessment and experience. There is increasing interest in using indocyanine green (ICG) fluorescence imaging to provide real-time information about tissue perfusion, vessel anatomy, and lymphatic drainage during pancreatic surgery. However, existing evidence is mostly from small retrospective series and case reports, and the overall benefit of ICG guidance in laparoscopic distal pancreatectomy has not been tested in a randomized clinical trial.

This prospective, single-center, parallel-group randomized controlled trial will compare ICG fluorescence-guided laparoscopic distal pancreatectomy (ICG-LDP) with standard laparoscopic distal pancreatectomy (S-LDP) in adult patients with pancreatic body and/or tail lesions scheduled for elective minimally invasive surgery. Eligible patients (age ≥ 18 years, BMI ≤ 40 kg/m², ECOG performance status 0-2, resectable lesion suitable for laparoscopy) will be randomized in a 1:1 ratio. Randomization will be stratified by intended spleen preservation (yes/no), malignant versus benign or premalignant diagnosis, and neoadjuvant therapy status. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes.

In the ICG-LDP arm, patients will undergo standard laparoscopic distal pancreatectomy with integration of four predefined ICG fluorescence steps using a near-infrared-enabled laparoscopic camera. A low-dose ICG injection will first be used for real-time mapping of the splenic artery and vein to support safer dissection and potentially reduce bleeding and conversion. A second injection after splenic vessel division (in spleen-preserving cases) will assess splenic perfusion and guide the decision to preserve or remove the spleen. A third injection before pancreatic transection will evaluate perfusion at the proposed stump margin; if perfusion is poor, the transection line may be adjusted to a better-perfused segment to reduce ischemia-related POPF. In oncologic cases, a higher-dose ICG injection during lymphadenectomy will highlight fluorescent lymph nodes along key vascular territories, which will be removed in addition to the standard nodal dissection.

In the standard S-LDP arm, the same laparoscopic approach, anesthesia, and surgical team will be used, but no ICG will be administered and no fluorescence imaging will be available. Decisions about dissection planes, pancreatic transection level, spleen preservation, and lymphadenectomy will be based on conventional white-light visualization and surgeon judgment. Perioperative management will be standardized in both groups, including prophylactic antibiotics, venous thromboembolism prophylaxis, stapled closure of the pancreatic remnant, routine drain placement with a predefined amylase-based removal protocol, multimodal analgesia, and an enhanced recovery after surgery pathway.

The primary outcome is the rate of clinically relevant postoperative pancreatic fistula (Grade B or C) within 90 days after surgery, according to the 2016 International Study Group on Pancreatic Surgery definition. Drain fluid amylase will be measured on postoperative days 1 and 3, and clinically relevant fistulas will be recorded. Secondary outcomes include intraoperative blood loss, operative time, conversion to open surgery, unplanned splenectomy when spleen preservation was intended, R0 resection rate, lymph node yield in malignant cases, length of hospital stay, time to first oral intake, time to drain removal, overall postoperative morbidity (Clavien-Dindo), post-pancreatectomy hemorrhage, delayed gastric emptying, 30-day and 90-day readmission, and 30-day and 90-day mortality.