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NCT Number: NCT07009119

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liver and GIT hospital , Minia University

Minya, 61519, Egypt

Location status: Recruiting

Location contact

Saleh K Saleh, MD

CONTACT

[email protected]

01201765401 ext. +2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laparoscopic pancreaticoduodenectomy

Procedure

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

Primary outcomes

  1. Pathological Assessment of Surgical Specimens

    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:

    • 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.

Secondary outcomes

  1. The rate of pancreatic fistula after pancreaticoduodenectomy

    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

  2. Operative time in minutes

    Time frame: From time of skin incision till time of skin closure

    Time spent in surgery

  3. Intra-operative blood loss

    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.

  4. Postoperative length of stay

    Time frame: up to 90 days

    the time from being admitted to hospital to discharge

  5. Amount of intraoperative blood transfusion

    Time frame: From start of surgery of every participant till skin closure

    Amount of intraoperative packed red blood cell units transfused intraoperative

  6. Length of postoperative surgical intensive care unit stay

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Rabeh K Saleh, MD

CONTACT

[email protected]

01220065443 ext. +2

Saleh K Saleh, MD

CONTACT

[email protected]

01201765401 ext. +2

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Feasibility, Safety and Short-term Oncosurgical Outcome of Laparoscopic Pancreaticoduodenectomy for Malignancy: A Single Centre Experience

Acronym: LPD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2025
Registry last updated
Aug 29, 2025

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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