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Compares treatment options for Pancreatic Neoplasms
Official title Indocyanine Green-Guided Versus Standard Laparoscopic Distal Pancreatectomy for Pancreatic Body and Tail Lesions
ClinicalTrials.gov ID: NCT07656571
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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.
- 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 treatment clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Alexandria, Egypt
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alexandria, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.