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2025-06-01
2026-06-01
2026-07-01
30
NCT07009119
Minia University
Minia University
INTERVENTIONAL
Laparoscopic Pancreaticoduodenectomy
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-05-20 | N/A | 2025-08-22 |
2025-06-05 | N/A | 2025-08-29 |
2025-06-06 | N/A | 2025-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: Laparoscopic pancreaticoduodenectomy Laparoscopic pancreaticoduodenectomy: 1. dissection 2. reconstruction | PROCEDURE: laparoscopic Pancreaticoduodenectomy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Pathological Assessment of Surgical Specimens | 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. | Assessed at the time of surgical specimen pathological evaluation (typically within 1-2 weeks post-surgery). |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The rate of pancreatic fistula after pancreaticoduodenectomy | 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 | 4 weeks postoperative |
| Operative time in minutes | Time spent in surgery | From time of skin incision till time of skin closure |
| Intra-operative blood loss | the amount of intra-operative blood loss (ml) at the end of surgery (d0): recorded by the anesthetist using a vacuum system. | day 0 (at the end of surgery) |
| Postoperative length of stay | the time from being admitted to hospital to discharge | up to 90 days |
| Amount of intraoperative blood transfusion | Amount of intraoperative packed red blood cell units transfused intraoperative | From start of surgery of every participant till skin closure |
| Length of postoperative surgical intensive care unit stay | Length of postoperative surgical intensive care unit stay In days | 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 . |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Saleh K Saleh, MD Phone Number: 01201765401 Email: salehkhairy@mu.edu.eg |
Study Contact Backup Name: Rabeh K Saleh, MD Phone Number: 01220065443 Email: Rabeh.Saleh@mu.edu.eg |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
