Minimally Invasive Pancreatico-duodenectomy

Pancreaticoduodenectomy Clinical Trial

— LPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807701
• Other study ID #: LPD
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: June 2018

Study information

• Verified date: June 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreaticoduodenectomy

Intervention

Procedure:
• Laparoscopic pancreaticoduodenectomy
Laparoscopic pancreaticoduodenectomy dissection reconstruction
• Open pancreaticoduodenectomy
Open pancreaticoduodenectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

References & Publications (6)

Croome KP, Farnell MB, Que FG, Reid-Lombardo KM, Truty MJ, Nagorney DM, Kendrick ML. Total laparoscopic pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: oncologic advantages over open approaches? Ann Surg. 2014 Oct;260(4):633-8; discussion 63 — View Citation

Dokmak S, Ftériche FS, Aussilhou B, Bensafta Y, Lévy P, Ruszniewski P, Belghiti J, Sauvanet A. Laparoscopic pancreaticoduodenectomy should not be routine for resection of periampullary tumors. J Am Coll Surg. 2015 May;220(5):831-8. doi: 10.1016/j.jamcolls — View Citation

El Nakeeb A, Askr W, Mahdy Y, Elgawalby A, El Sorogy M, Abu Zeied M, Abdallah T, Abd Elwahab M. Delayed gastric emptying after pancreaticoduodenectomy. Risk factors, predictors of severity and outcome. A single center experience of 588 cases. J Gastrointe — View Citation

El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single cen — View Citation

Guerra F, Levi Sandri GB, Amore Bonapasta S, Farsi M, Coratti A. The role of robotics in widening the range of application of minimally invasive surgery for pancreaticoduodenectomy. Pancreatology. 2016 Mar-Apr;16(2):293-4. doi: 10.1016/j.pan.2015.12.007. — View Citation

Senthilnathan P, Srivatsan Gurumurthy S, Gul SI, Sabnis S, Natesan AV, Palanisamy NV, Praveen Raj P, Subbiah R, Ramakrishnan P, Palanivelu C. Long-term results of laparoscopic pancreaticoduodenectomy for pancreatic and periampullary cancer-experience of 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of hospital stay	hospital stay	one month
Secondary	postoperative pancreatic fistula	Postoperative pancreatic ?stula was defined as proposed by the international study group of pancreatic ?stula (ISGPF) as any measurable volume of ?uid 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
Secondary	operative time	total operative time	intraoperative hours
Secondary	blood loss	estimated blood loss intraoperative	intraoperative hours

External Links

•   mansoura university