Minimally Invasive Pancreatico-duodenectomy (LPD)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Pancreaticoduodenectomy||Procedure: Laparoscopic pancreaticoduodenectomy Procedure: Open pancreaticoduodenectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
Procedure: Laparoscopic pancreaticoduodenectomy
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
Other Name: O PD
- duration of hospital stay [ Time Frame: one month ]hospital stay
- 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 .
- operative time [ Time Frame: intraoperative hours ]total operative time
- blood loss [ Time Frame: intraoperative hours ]estimated blood loss intraoperative
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
|Study Director:||Ayman El Nakeeb, MD||Mansoura University|