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

NCT07656571 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-06-18

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

ICG Fluorescence-Guided Laparoscopic Distal Pancreatectomy

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

PROCEDURE

Standard Laparoscopic Distal Pancreatectomy

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

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-09
Primary Completion
2026-12-01
Completion
2027-02-01

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07656571 on ClinicalTrials.gov