Overview

This trial is active, not recruiting.

Condition pancreaticoduodenectomy
Treatments laparoscopic pancreaticoduodenectomy, open pancreaticoduodenectomy
Sponsor Mansoura University
Start date May 2016
End date June 2018
Trial size 40 participants
Trial identifier NCT02807701, LPD

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Laparoscopic pancreaticoduodenectomy Under general anesthesia, the patient is placed in a supine position with the legs abducted. Carbon dioxide pneumoperitoneum is established using an open technique through a 10-mm trocar over the umbilicus. A 30 telescope is inserted to examine the peritoneal cavity, liver, stomach, and mesentric vessels.Then 4 to 6 more trocars are inserted under direct vision in the epigastrium and upper quadrants dissection reconstruction
laparoscopic pancreaticoduodenectomy LPD
Laparoscopic pancreaticoduodenectomy dissection reconstruction
(Active Comparator)
Open pancreaticoduodenectomy Abdomen is opened from the Bilateral Subcostal incision. (Chevron's Incision) 2. Abdominal cavity is explored for metastasis especially in liver, base of mesentary, mesocolon and pelvis. Dissection Reconstruction Pancreaticogastrostomy Hepaticojejunostomy is next- Done in single layer and can be performed in interrupted or continuous fashion. Gastrojejunostomy is the final step of reconstruction.
open pancreaticoduodenectomy O PD
Open pancreaticoduodenectomy

Primary Outcomes

Measure
duration of hospital stay
time frame: one month

Secondary Outcomes

Measure
postoperative pancreatic fistula
time frame: 30 days
operative time
time frame: intraoperative hours
blood loss
time frame: intraoperative hours

Eligibility Criteria

Male or female participants up to 65 years old.

Inclusion Criteria: 1. Age from less than 70 years. 2. Tumor size less than or equal 3cm. 3. No vascular invasion. Exclusion Criteria: 1. Multiple prior abdominal surgeries. 2. Body mass index >40. 3. Locally advanced tumors . 4. Inability to withstand prolonged anesthesia. 5. Tumor size more than 3 cm. 6. Patients who received chemoradiotherapy. 7. Pregnant females. 8. Patients with cirrhotic liver.

Additional Information

Official title Comparative Study Between Minimally Invasive Pancreatico-duodenectomy and Open Pancreatico-duodenectomy for Periampullary Tumors
Description 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 despite several improvements in surgical devices and techniques that have allowed surgeons to approach the pancreas laparoscopically, laparoscopic PD remains challenging. LPD represents one of the most advanced abdominal operations owing to the necessity of a complex dissection and reconstruction. Recent reports note that complete laparoscopic PD including laparoscopic resection and reconstruction is both technically feasible and safe. 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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Mansoura University.