Minimally invasive (laparoscopic) Whipple procedure for pancreatic and periampullary tumors

Feasibility, Safety and Short-term Oncosurgical Outcome of Laparoscopic Pancreaticoduodenectomy for Malignancy: A Single Centre Experience

This trial tests whether a laparoscopic Whipple operation is safe and feasible for people with resectable pancreatic head or periampullary cancers who do not have major blood vessel involvement.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Minia University (Academic / other)
• Locations: 1 site (Minya)
• Trial ID: NCT07009119 on ClinicalTrials.gov

What this trial studies

This is a prospective single-center protocol offering complete laparoscopic pancreaticoduodenectomy (resection and reconstruction) to patients with resectable pancreatic head, ampullary, duodenal, or distal bile duct tumors. Eligible patients have no distant metastases and no radiologic involvement of the superior mesenteric or portal veins or major arterial encasement. Surgeons perform the complex laparoscopic dissection and anastomoses and record perioperative, surgical and early oncologic outcomes, including complications such as pancreatic fistula. The aim is to document safety, operative feasibility, and short-term morbidity in a center experienced with hepatobiliary surgery.

Who should consider this trial

Good fit: Adults with resectable pancreatic head or periampullary tumors, no metastasis, preserved vascular planes on imaging, and who are fit for major laparoscopic surgery are the ideal candidates.

Not a fit: Patients with distant metastases, vascular invasion or unresectable tumors, those unfit for major surgery, or those requiring non-Whipple pancreatic resections are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the laparoscopic approach could reduce surgical trauma and speed recovery while maintaining oncologic outcomes similar to open surgery.

How similar studies have performed: High-volume centers have reported that laparoscopic pancreaticoduodenectomy can be technically feasible and safe, but comparative evidence versus open surgery remains limited and outcomes are variable.

Eligibility criteria

Inclusion Criteria:

* Patients meeting the curative treatment intent in accordance with clinical guidelines:

  * No evidence of metastasis.
  * Radiological non-involvement of superior mesenteric vein \& portal vein.
  * Preserved fat planes between celiac axis, hepatic artery \& superior mesenteric artery.
* Patients presenting with resectable pancreatic head cancer, cholangiocarcinoma, duodenal cancer and ampullary tumours who are fit for laparoscopic pancreaticoduodenectomy.

Exclusion Criteria:

* Unfit patients for surgery due to severe medical illness.
* Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
* Irresectable tumors in diagnostic laparoscopy.
* Patients requiring left, central or total pancreatectomy or other palliative surgery.
* History of other malignant disease.
* Pregnant or breast-feeding women.
* Patients with serious mental disorders.
* Patients with vascular invasion and requiring vascular resection as evaluated by the multidisciplinary team team according to abdominal imaging data.
* Pancreatoduodenectomy for other diagnosis like cystic lesions, benign tumors or chronic calcific pancreatitis
* Patients with cirrhotic liver.
* Patients refused to participate in the study.

Where this trial is running

Minya

• Liver and GIT hospital , Minia University — Minya, Egypt (Recruiting)

Study contacts

• Principal investigator: Saleh K Saleh, MD — Minia University
• Study coordinator: Saleh K Saleh, MD

Conditions Pancreatic Cancer; Pancreatic Fistula; Periampullary Cancer