Minimally Invasive Pancreatico-duodenectomy

Study Overview
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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.

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

Official Title
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Comparative Study Between Minimally Invasive Pancreatico-duodenectomy and Open Pancreatico-duodenectomy for Periampullary Tumors

Conditions
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Pancreaticoduodenectomy

Intervention / Treatment
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* Procedure: Laparoscopic pancreaticoduodenectomy
* Procedure: Open pancreaticoduodenectomy


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

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic pancreaticoduodenectomy<br>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 | Procedure: Laparoscopic pancreaticoduodenectomy<br>* Laparoscopic pancreaticoduodenectomy dissection reconstruction<br>* Other names: LPD;|
| Active Comparator: Open pancreaticoduodenectomy<br>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. | Procedure: Open pancreaticoduodenectomy<br>* Open pancreaticoduodenectomy<br>* Other names: O PD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of hospital stay | hospital stay | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pancreatic fistula | 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 . | 30 days | 
| operative time | total operative time | intraoperative hours | 
| blood loss | estimated blood loss intraoperative | intraoperative hours |