Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Recruiting Not applicable

Laparoscopic Pancreaticoduodenectomy

NCT07009119 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-06-01
Last updated
2025-08-29

Condition(s) studied

Pancreatic CancerPancreatic FistulaPeriampullary Cancer

Investigational drug(s) / intervention(s)

laparoscopic Pancreaticoduodenectomy

laparoscopic Pancreaticoduodenectomy: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

  • Pathological Assessment of Surgical Specimens — Assessed at the time of surgical specimen pathological evaluation (typically within 1-2 weeks post-surgery).
    Evaluation of the surgical specimens will include: * Number of lymph nodes harvested: Total count of lymph nodes excised and examined during surgery. * Resected margin status: Assessment of the presence or absence of tumor cells at the resection margins, classified as negative (R0), microscopic positive (R1), or macroscopic positive (R2). * Ratio of positive lymph nodes to total lymph nodes harvested: Proportion (%) calculated by dividing the number of histopathologically confirmed metastatic lymph nodes by the total number of lymph nodes retrieved.

Trial sites (1)

FacilityCityRegionStatus
Liver and GIT hospital , Minia University Minya Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07009119 on ClinicalTrials.gov ↗ ← All trials in Egypt