Laparoscopic versus open pancreaticoduodenectomy outcomes

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 monocentric, prospective, randomized controlled trial will enroll 90 adults with resectable pancreatic head or periampullary lesions and randomize them 1:1 to laparoscopic pancreaticoduodenectomy (LPD) or open pancreaticoduodenectomy (OPD). The primary outcome is overall morbidity measured by the Clavien–Dindo classification at 90 days postoperatively. Secondary outcomes include oncologic measures (lymph node harvest, margin status), perioperative metrics (operative time, blood loss), and postoperative recovery (length of stay, readmissions). The trial uses a prospectively maintained database and follows CONSORT reporting standards.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years.
* Histologically confirmed or clinically suspected lesions of: Pancreatic head adenocarcinoma, Ampullary carcinoma, Distal cholangiocarcinoma, Duodenal adenocarcinoma, Pancreatic neuroendocrine tumors, or Intraductal Papillary Mucinous Neoplasm(IPMN) .
* Resectable disease based on preoperative imaging.
* Eastern Cooperative Oncology Group(ECOG) performance status 0-2.
* American Society of Anesthesiologists(ASA )classification I-III.
* Patients able to provide informed consent.

Exclusion Criteria:

* Emergency surgery.
* Previous pancreatic surgery.
* Concurrent major abdominal procedures .
* ASA classification IV or higher.
* Metastatic disease identified preoperatively.
* Locally advanced unresectable disease.
* Active infection or sepsis at time of surgery.
* Severe cardiopulmonary comorbidities precluding major surgery.
* Pregnancy.
* Procedures requiring Total Pancreatectomy, Distal Pancreatectomy, or Enucleation .

Where it's running

• Liver and GIT hospital , Minia University
  Minya, Minya Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Saleh K Saleh, MD — Minia University
• Study coordinator: Saleh K Saleh, MD
• Email: salehkhairy@mu.edu.eg
• Phone: 01201765401

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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.