Laparoscopic Pancreaticoduodenectomy
Recruiting · NCT07009119 · Interventional (participants receive a specific treatment) · Lead sponsor: Minia University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Patients meeting the curative treatment intent in accordance with clinical guidelines:
- No evidence of metastasis.
- Radiological non-involvement of superior mesenteric vein \& portal vein.
- Preserved fat planes between celiac axis, hepatic artery \& superior mesenteric artery.
- Patients presenting with resectable pancreatic head cancer, cholangiocarcinoma, duodenal cancer and ampullary tumours who are fit for laparoscopic pancreaticoduodenectomy.
Exclusion criteria
- Unfit patients for surgery due to severe medical illness.
- Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
- Irresectable tumors in diagnostic laparoscopy.
- Patients requiring left, central or total pancreatectomy or other palliative surgery.
- History of other malignant disease.
- Pregnant or breast-feeding women.
- Patients with serious mental disorders.
- Patients with vascular invasion and requiring vascular resection as evaluated by the multidisciplinary team team according to abdominal imaging data.
- Pancreatoduodenectomy for other diagnosis like cystic lesions, benign tumors or chronic calcific pancreatitis
- Patients with cirrhotic liver.
- Patients refused to participate in the study.
Where it is running
1 location listed.
- Liver and GIT hospital , Minia University - Minya, Egypt