Liver and GIT hospital , Minia University
Minya, 61519, Egypt
Location status: Recruiting
NCT Number: NCT07009119
Laparoscopic pancreaticoduodenectomy was first performed by Garner and Pomp in 1994. This is a technically difficult, time consuming and high rate of complication procedure. The reason is that duodenum and head of pancreas locate deeply in retroperitoneum and are surrounded by important structures such as inferior vena cava, abdominal aorta, superior mesenteric artery, superior mesenteric vein (SMV), portal vein (PV) and hepatic arteries. Injuring these structures during the surgery can lead to life-threatening complications. Moreover, doing anastomoses through laparoscopy, especially pancreatic anastomosis, is more difficult and takes more time than through open approach. 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 study, investigators evaluate the safety and feasibility of surgical and oncological outcomes of minimally invasive PD.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Minya, 61519, Egypt
Location status: Recruiting
Open pancreaticoduodenectomy (PD) was 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 study, investigators evaluate the safety and feasibility of surgical and oncological outcomes of minimally invasive PD.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patient is positioned in French position (right arm in, left arm abducted 90°), with a suprapubic area reserved for Pfannenstiel incision. A 6-port technique is used: sub-umbilical (12 mm), four semi-circular trocars (two 12 mm, two 5 mm), and a sub-xiphoid trocar for liver retraction. Laparoscopic pancreaticoduodenectomy (LPD) proceeds if no vascular invasion/metastasis is found. Key steps include Kocher's maneuver, vessel ligation (gastroepiploic, gastric, gastroduodenal), lymphadenectomy (stations 5-17), pancreatic neck transection, and jejunal division. Reconstruction involves duct-to-mucosa pancreaticojejunostomy (or invaginating if duct unfound), hepaticojejunostomy, and stapled gastrojejunostomy. Margins are examined post-resection. Harmonic scalpel/Ligasure and staplers are used.
Other names: LPD
Time frame: Assessed at the time of surgical specimen pathological evaluation (typically within 1-2 weeks post-surgery).
Evaluation of the surgical specimens will include:
Time frame: 4 weeks postoperative
On or after the third postoperative day, the drain outflow of any detectable volume was treated as a pancreatic fistula with an amylase content larger than three times the upper normal serum amylase value
Time frame: From time of skin incision till time of skin closure
Time spent in surgery
Time frame: day 0 (at the end of surgery)
the amount of intra-operative blood loss (ml) at the end of surgery (d0): recorded by the anesthetist using a vacuum system.
Time frame: up to 90 days
the time from being admitted to hospital to discharge
Time frame: From start of surgery of every participant till skin closure
Amount of intraoperative packed red blood cell units transfused intraoperative
Time frame: From the date of admission to surgical intensive care unit after surgery to the date of discharge to ward or death whichever comes first, assessed up to 3 months .
Length of postoperative surgical intensive care unit stay In days
Contact information is provided by the study sponsor or research team.
Minia University
Other
Feasibility, Safety and Short-term Oncosurgical Outcome of Laparoscopic Pancreaticoduodenectomy for Malignancy: A Single Centre Experience
Acronym: LPD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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