Minimally Invasive Pancreatico-duodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pancreaticoduodenectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Laparoscopic pancreaticoduodenectomy

Intervention Type PROCEDURE

Laparoscopic pancreaticoduodenectomy

1. dissection
2. reconstruction

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.

Group Type ACTIVE_COMPARATOR

Open pancreaticoduodenectomy

Intervention Type PROCEDURE

Open pancreaticoduodenectomy

Interventions

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Laparoscopic pancreaticoduodenectomy

Laparoscopic pancreaticoduodenectomy

1. dissection
2. reconstruction

Intervention Type PROCEDURE

Open pancreaticoduodenectomy

Intervention Type PROCEDURE

Other Intervention Names

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LPD O PD

Eligibility Criteria

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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.

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No