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Minimally Invasive Pancreatico-duodenectomy (LPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02807701
Recruitment Status : Unknown
Verified June 2016 by Ayman El Nakeeb, Mansoura University.
Recruitment status was:  Active, not recruiting
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Ayman El Nakeeb, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Pancreaticoduodenectomy Procedure: Laparoscopic pancreaticoduodenectomy Procedure: Open pancreaticoduodenectomy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study Between Minimally Invasive Pancreatico-duodenectomy and Open Pancreatico-duodenectomy for Periampullary Tumors
Study Start Date : May 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Active Comparator: 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
Procedure: Laparoscopic pancreaticoduodenectomy

Laparoscopic pancreaticoduodenectomy

  1. dissection
  2. reconstruction
Other Name: LPD

Active Comparator: 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.

Procedure: Open pancreaticoduodenectomy
Open pancreaticoduodenectomy
Other Name: O PD




Primary Outcome Measures :
  1. duration of hospital stay [ Time Frame: one month ]
    hospital stay


Secondary Outcome Measures :
  1. postoperative pancreatic fistula [ Time Frame: 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 .

  2. operative time [ Time Frame: intraoperative hours ]
    total operative time

  3. blood loss [ Time Frame: intraoperative hours ]
    estimated blood loss intraoperative



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807701


Sponsors and Collaborators
Mansoura University
Investigators
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Study Director: Ayman El Nakeeb, MD Mansoura University

Additional Information:
Publications of Results:

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Responsible Party: Ayman El Nakeeb, Gastroenterology surgical center, mansoura university, Mansoura University
ClinicalTrials.gov Identifier: NCT02807701    
Other Study ID Numbers: LPD
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes