Clinical trial NCT07009119: Laparoscopic Pancreaticoduodenectomy
Official title: Feasibility, Safety and Short-term Oncosurgical Outcome of Laparoscopic Pancreaticoduodenectomy for Malignancy: A Single Centre Experience
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Pancreatic Fistula
Periampullary Cancer
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: State of resection margins after pathological assessment
timeFrame: It takes 7 days after surgery for the pathological assessment to be completed
measure: Lymph node yield after surgery
timeFrame: It takes 7 days after surgery for the pathological assessment to be completed
measure: Ratio of positive lymph nodes to total number of lymph nodes harvested
timeFrame: It takes 7 days after surgery for the pathological assessment to be completed
Secondary outcomes:
measure: The rate of pancreatic fistula after pancreaticoduodenectomy
timeFrame: 4 weeks postoperative
measure: Operative time in minutes
timeFrame: From time of skin incision till time of skin closure
measure: Intra-operative blood loss
timeFrame: day 0 (at the end of surgery)
measure: Postoperative length of stay
timeFrame: up to 90 days
measure: Amount of intraoperative blood transfusion
timeFrame: From start of surgery of every participant till skin closure
measure: Length of postoperative surgical intensive care unit stay
timeFrame: 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 .
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Liver and GIT hospital , Minia University
Study officials:
affiliation: Minia University
name: Saleh K Saleh, MD
role: PRINCIPAL_INVESTIGATOR
References: