Pancreaticoduodenectomy
Conditions
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
Interventions
PROCEDURELaparoscopic pancreaticoduodenectomy
Laparoscopic pancreaticoduodenectomy 1. dissection 2. reconstruction
PROCEDUREOpen pancreaticoduodenectomy
Open pancreaticoduodenectomy
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| duration of hospital stay | one month | hospital stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 . |
| operative time | intraoperative hours | total operative time |
| blood loss | intraoperative hours | estimated blood loss intraoperative |
Outcome results
None listed