Laparoscopic Pancreaticoduodenectomy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Pathological Assessment of Surgical Specimens [Срок оценки: Assessed at the time of surgical specimen pathological evaluation (typically within 1-2 weeks post-surgery).]

Вторичные конечные точки (6)

• The rate of pancreatic fistula after pancreaticoduodenectomy [Срок оценки: 4 weeks postoperative]
• Operative time in minutes [Срок оценки: From time of skin incision till time of skin closure]
• Intra-operative blood loss [Срок оценки: day 0 (at the end of surgery)]
• Postoperative length of stay [Срок оценки: up to 90 days]
• Amount of intraoperative blood transfusion [Срок оценки: From start of surgery of every participant till skin closure]
• Length of postoperative surgical intensive care unit stay [Срок оценки: 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 .]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Liver and GIT hospital , Minia University — Minya

Идентификаторы

NCT: NCT07009119 · 1496/04/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗