Laparoscopic Pancreaticoduodenectomy

NCT ID: NCT07009119

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-07-01

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.

Conditions

Pancreatic Cancer; Pancreatic Fistula; Periampullary Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic pancreaticoduodenectomy

Laparoscopic pancreaticoduodenectomy:

1. dissection

2. reconstruction

Group Type: OTHER

laparoscopic Pancreaticoduodenectomy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

LPD

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Saleh Khairy Saleh MD

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saleh K Saleh, MD

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

Liver and GIT hospital , Minia University

Minya, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Saleh K Saleh, MD

Role: CONTACT

salehkhairy@mu.edu.eg

01201765401 ext. +2

Rabeh K Saleh, MD

Role: CONTACT

Rabeh.Saleh@mu.edu.eg

01220065443 ext. +2

Facility Contacts

Saleh K Saleh, MD

Role: primary

salehkhairy@mu.edu.eg

01201765401 ext. +2

Other Identifiers

1496/04/2025

Identifier Type: -

Identifier Source: org_study_id