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

ConditionsPancreatic NeoplasmsPancreatic Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ICG Fluorescence-Guided Laparoscopic Distal Pancreatectomy

    Procedure/Surgery

    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

  • Standard Laparoscopic Distal Pancreatectomy

    Procedure/Surgery

    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

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: ICG Fluorescence-Guided Laparoscopic Distal Pancreatectomy (ICG-LDP)Experimental treatment 1 intervention
Group B: Standard Laparoscopic Distal Pancreatectomy (S-LDP)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of Clinically Relevant Postoperative Pancreatic Fistula (Grade B/C)

Clinically relevant postoperative pancreatic fistula (CR-POPF) defined as Grade B or Grade C fistula according to the 2016 International Study Group on Pancreatic Surgery (ISGPS) criteria. Drain amylase will be measured on postoperative days 1 and 3 in all patients. Biochemical leaks (formerly Grade A) will be recorded but will not be counted as CR-POPF events

Time frame
Within 90 days after surgery

Secondary outcomes

1

Total Operative Time

Total operative time in minutes from skin incision to skin closure recorded by the anesthetic or operating room records

Time frame
Intraoperative (skin incision to skin closure)
2

Intraoperative Blood Loss

Estimated intraoperative blood loss in milliliters, calculated from suction canister volume (minus irrigation) and weighed surgical sponges as documented in the anesthetic record

Time frame
Intraoperative (during operation)
3

Rate of Conversion to Open Surgery

Proportion of patients requiring conversion from laparoscopic to open distal pancreatectomy for any reason, as recorded in the operative report; indications for conversion (e.g., bleeding, difficult anatomy) will be documented

Time frame
During operation
4

R0 Resection Rate

Proportion of malignant or premalignant cases achieving R0 resection, defined as microscopically margin-negative resection with no tumor cells at any transection or circumferential margin on final histopathology.

Time frame
Within 30 days after surgery (on final histopathology report)

Other outcomes

Sponsors and contacts

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Alexandria University

Lead sponsor

Source ClinicalTrials.gov
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