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

Sponsor
Alexandria University
Study ID
NCT07656571
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ICG Fluorescence-Guided Laparoscopic Distal Pancreatectomy — PROCEDURE
    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
    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

Study Details

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.

Key Dates

First listed
Jun 18, 2026
Start date
Jun 9, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ICG Fluorescence-Guided Laparoscopic Distal Pancreatectomy (ICG-LDP)
    Patients in this arm will undergo standard laparoscopic distal pancreatectomy with integration of indocyanine green (ICG) near-infrared fluorescence imaging at four predefined steps: splenic vessel mapping, splenic perfusion assessment (in spleen-preserving cases), pancreatic stump perfusion assessment before transection, and lymph node mapping in malignant cases. All other perioperative care will follow the standardized institutional protocol.
  • Active Comparator: Standard Laparoscopic Distal Pancreatectomy (S-LDP)
    Patients in this arm will undergo standard laparoscopic distal pancreatectomy using the same port placement, anesthetic protocol, and operative team as the ICG-LDP arm, but without administration of ICG and without access to near-infrared fluorescence imaging. Decisions regarding dissection planes, pancreatic transection line, spleen preservation, and lymphadenectomy will rely on conventional white-light visualization and surgeon judgment. Perioperative management will be identical to the experimental arm

Primary Outcome Measure

Rate of Clinically Relevant Postoperative Pancreatic Fistula (Grade B/C) [ Time Frame: Within 90 days after surgery ]

Central Contacts

  • Ahmed M Farid, Lecturer, MD, MS
    +20227196753
    [email protected]
  • Mohamed I Kassem, Professor, MD
    +201001224750

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