Minimally Invasive Pancreatico-duodenectomy

NCT02807701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-03-03

No results posted yet for this study

Summary

Open pancreaticoduodenectomy (PD) is the standard treatment for a wide array of periampullary and pancreatic diseases including malignant and benign conditions. The outcome of PD has improved over the last two decades due to advances in surgical techniques, anesthesia and perioperative care. Although studies from high volume centers demonstrate reduce in the operative mortality to less than 3%, the postoperative morbidity rate is still ranging from 30% to 60%. Laparoscopic surgery is being used increasingly as a less invasive alternative to traditional interventions for pancreatic resection. Laparoscopic pancreaticoduodenectomy (LPD) is a difficult procedure that has become increasingly popular. Nevertheless, comparative data on outcomes remain limited. In this prospective randomized study, investigators evaluate the safety and feasibility of surgical and oncological outcomes of minimally invasive PD compared to conventional open PD.

Conditions

  • Pancreaticoduodenectomy

Interventions

PROCEDURE

Laparoscopic pancreaticoduodenectomy

Laparoscopic pancreaticoduodenectomy 1. dissection 2. reconstruction

PROCEDURE

Open pancreaticoduodenectomy

Open pancreaticoduodenectomy

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Ayman El Nakeeb, MD · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-06-30
Completion
2018-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02807701 on ClinicalTrials.gov