Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07009119

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

Led by Minia University · Updated on 2025-08-29

30

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating laparoscopic pancreaticoduodenectomy (LPD), a minimally invasive surgical technique used to treat pancreatic and periampullary cancers as well as other related conditions. The study aims to assess the safety, feasibility, and short-term oncological outcomes of LPD, a complex and technically demanding procedure that involves removing parts of the pancreas and surrounding structures. Although open pancreaticoduodenectomy has been the standard treatment, laparoscopic surgery is being explored as a less invasive alternative with the potential to reduce complications. The study involves performing laparoscopic pancreaticoduodenectomy using a 6-port technique with specific patient positioning and surgical steps such as vessel ligation, lymphadenectomy, and reconstruction of digestive tract connections. Surgeons use advanced tools like harmonic scalpels, Ligasure, and staplers during the procedure. This approach is applied only if no vascular invasion or metastasis is detected. The study focuses on patients with resectable pancreatic head cancer, cholangiocarcinoma, duodenal cancer, and ampullary tumors who are fit for this surgery. Participants undergo careful screening to confirm eligibility and avoid inoperable or metastatic cases. Researchers assess surgical specimens pathologically within 1 to 2 weeks after surgery and monitor outcomes including pancreatic fistula rates, operative time, blood loss, blood transfusions, length of hospital stay, and intensive care unit duration over up to 90 days. The study collects detailed data to evaluate the short-term safety and effectiveness of laparoscopic pancreaticoduodenectomy for cancer treatment.

CONDITIONS

Brief Title

Laparoscopic Pancreaticoduodenectomy

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients meeting curative treatment intent according to clinical guidelines
  • No evidence of metastasis
  • No radiological involvement of superior mesenteric vein and portal vein
  • Preserved fat planes between celiac axis, hepatic artery, and superior mesenteric artery
  • Patients with resectable pancreatic head cancer, cholangiocarcinoma, duodenal cancer, or ampullary tumors
  • Patients fit for laparoscopic pancreaticoduodenectomy
  • Age between 18 and 75 years
Not Eligible

You will not qualify if you...

  • Patients unfit for surgery due to severe medical illness
  • Patients with distant metastases including peritoneal, liver, or distant lymph node metastases
  • Patients with involvement of other organs making surgery inoperable
  • Patients with irresectable tumors found in diagnostic laparoscopy
  • Patients requiring other surgeries such as left, central, or total pancreatectomy or palliative surgery
  • History of other malignant diseases
  • Pregnant or breastfeeding women
  • Patients with serious mental disorders
  • Patients with vascular invasion requiring vascular resection
  • Patients undergoing pancreatoduodenectomy for benign cystic lesions, benign tumors, or chronic calcific pancreatitis
  • Patients with cirrhotic liver
  • Patients who refuse to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day 0 up to 90 days post-surgery

Participants undergo laparoscopic pancreaticoduodenectomy, a minimally invasive surgery involving complex dissection and reconstruction of the pancreas area.

Hospital stay including surgery and postoperative surgical intensive care unit stay

Post-operative Follow-up

Duration - Up to 4 weeks post-surgery

Participants are monitored for surgical outcomes including pancreatic fistula rate and recovery progress after surgery.

Approximately 1 to 2 visits post-surgery

Trial Site Locations

Total: 1 location

1

Liver and GIT hospital , Minia University

Minya, Egypt, 61519

Actively Recruiting

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Research Team

S

Saleh K Saleh, MD

R

Rabeh K Saleh, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Frequently Asked Questions

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