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

NCT07656571 | Recruiting

• 1 other identifier: 0308015
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Pancreatic Neoplasms; Pancreatic Cancer

Keywords

Laparoscopic distal pancreatectomy; Distal pancreatectomy; Pancreatic body and tail lesions; Pancreatic ductal adenocarcinoma; ICG fluorescence imaging; ICG-guided surgery

Outcome Measures

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

  Within 90 days after surgery

Secondary Outcomes (5)

• Total Operative Time

  Intraoperative (skin incision to skin closure)

• Intraoperative Blood Loss

  Intraoperative (during operation)

• Rate of Conversion to Open Surgery

  During operation

• R0 Resection Rate

  Within 30 days after surgery (on final histopathology report)

• Length of Postoperative Hospital Stay

  From day of surgery until hospital discharge (up to 90 days)

Study Arms (2)

ICG Fluorescence-Guided Laparoscopic Distal Pancreatectomy (ICG-LDP)

EXPERIMENTAL

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.

Procedure: ICG Fluorescence-Guided Laparoscopic Distal Pancreatectomy

Standard Laparoscopic Distal Pancreatectomy (S-LDP)

ACTIVE COMPARATOR

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

Procedure: Standard Laparoscopic Distal Pancreatectomy

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

ICG Fluorescence-Guided Laparoscopic Distal Pancreatectomy (ICG-LDP)

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

Standard Laparoscopic Distal Pancreatectomy (S-LDP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Alexandria University

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Ahmed M Farid, Lecturer, MD, MS

CONTACT

+20227196753; ahmed.farid@alexmed.edu.eg

Mohamed I Kassem, Professor, MD

CONTACT

+201001224750

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-label surgical trial with respect to the operating team. Postoperative ward physicians, nurses, radiologists, and the primary outcome assessors are blinded to group assignment. Data analysts will be blinded to group allocation during the main analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, MD, MS

Model Details: Prospective, single-center, two-arm parallel-group randomized controlled trial comparing ICG fluorescence-guided laparoscopic distal pancreatectomy with standard laparoscopic distal pancreatectomy in adult patients with pancreatic body and tail lesions.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

EG (1)