Indocyanine green–guided laparoscopic distal pancreatectomy vs standard approach for pancreatic body/tail lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-center trial compares ICG fluorescence-guided laparoscopic distal pancreatectomy (ICG-LDP) with standard laparoscopic distal pancreatectomy (S-LDP) for adults with resectable lesions of the pancreatic body or tail. Eligible patients are aged 18 or older, have BMI up to 40 kg/m², ECOG 0-2, and adequate liver function, and are planned for elective minimally invasive surgery. Participants are randomized 1:1, with stratification by planned spleen preservation, to determine if ICG guidance reduces clinically relevant postoperative pancreatic fistula and improves intraoperative decision making. The study builds on limited prior evidence suggesting potential perfusion and anatomical advantages from ICG imaging, aiming to provide higher-level data. Primary outcomes focus on postoperative complications, with secondary endpoints including operative details and recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Faculty of Medicine, Alexandria University
  Alexandria, Egypt Recruiting

Study contacts

• Study coordinator: Ahmed M Farid, Lecturer, MD, MS
• Email: ahmed.farid@alexmed.edu.eg
• Phone: +20227196753

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.