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Minimally Invasive Pancreatico-duodenectomy (LPD)

M

Mansoura University

Status

Completed

Conditions

Pancreaticoduodenectomy

Treatments

Procedure: Laparoscopic pancreaticoduodenectomy
Procedure: Open pancreaticoduodenectomy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

40 patients

Sex

All

Ages

Under 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Laparoscopic pancreaticoduodenectomy
Active Comparator group
Description:
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
Treatment:
Procedure: Laparoscopic pancreaticoduodenectomy
Open pancreaticoduodenectomy
Active Comparator group
Description:
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.
Treatment:
Procedure: Open pancreaticoduodenectomy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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