Minimally Invasive Pancreatico-duodenectomy

Not Applicable

Completed

• Conditions: Pancreaticoduodenectomy
• Interventions: Procedure: Laparoscopic pancreaticoduodenectomy; Procedure: Open pancreaticoduodenectomy

• Registration Number: NCT02807701
• Lead Sponsor: Mansoura University

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-06
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-21
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic pancreaticoduodenectomy	Laparoscopic pancreaticoduodenectomy	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 1. dissection 2. reconstruction
Open pancreaticoduodenectomy	Open pancreaticoduodenectomy	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.

Primary Outcome Measures

Name	Time	Method
duration of hospital stay	one month	hospital stay

Secondary Outcome Measures

Name	Time	Method
postoperative pancreatic fistula	30 days	Postoperative pancreatic fistula was defined as proposed by the international study group of pancreatic fistula (ISGPF) as any measurable volume of fluid on or after postoperative day (POD) 3 with amylase content greater than 3 times the serum amylase activity, and classified into grades A, B, C .
blood loss	intraoperative hours	estimated blood loss intraoperative
operative time	intraoperative hours	total operative time