Laparoscopic Pancreaticoduodenectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMinia University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • laparoscopic Pancreaticoduodenectomy

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Laparoscopic pancreaticoduodenectomyOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessed at the time of surgical specimen pathological evaluation (typically within 1-2 weeks post-surgery).

Secondary outcomes

1

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

Time frame
4 weeks postoperative
2

Operative time in minutes

Time spent in surgery

Time frame
From time of skin incision till time of skin closure
3

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.

Time frame
day 0 (at the end of surgery)
4

Postoperative length of stay

the time from being admitted to hospital to discharge

Time frame
up to 90 days

Other outcomes

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