Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma

Официальное название

Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial

Обзор

Background: Pancreatic cancer (PC) is one of the most aggressive malignant neoplasms with poor outcomes. Pancreatoduodenectomy (PD) is the only curative treatment for PC. Minimally invasive surgery has been progressively developed, first with the advent of hybrid-laparoscopy and recently with the total laparoscopy surgeries, but a number of issues are currently being debated, including the superiority between total laparoscopic pancreaticoduodenectomy (TLPD)and the open pancreaticoduodenectomy (OPD). Studies comparing these two surgery techniques are merging and randomized controlled trials (RCT) are lacking but clearly required. Methods/design: TJDBPS07 is a multicenter prospective, randomized controlled, trial comparing TLPD and OPD in pancreatic cancers. A total of 200 patients with pancreatic cancer underwent PD will be randomly allocated to the TLPD group or OPD group with an enhanced recovery after surgery (ERAS) pattern. The trial's aim is to exploring the overall survival (OS), disease free survival (DFS) and quality of life. The duration of the entire trial is seven years including prearrangement, a presumably five-year follow-up and analyses. Discussion: Despite the fact there are several RCTs comparing minimally invasive pancreaticoduodenectomy (MIPD) and Open approach or LPD versus OPD. This trial will be the first comparing TLPD and OPD in a large multicenter setting. TJDBPS01 trial is hypothesized to assess whether TLPD has superiority over OPD in recovery and other aspects.

Вмешательства

• Процедура TLPD Surgery
  TLPD
• Процедура OPD Surgery
  OPD

Первичные конечные точки

• 5-year overall survival [Срок оценки: 5 year]

Вторичные конечные точки (7)

• overall survival [Срок оценки: 5 years]
• disease-free survival [Срок оценки: 5 years]
• 90-day mortality [Срок оценки: 90 days]
• complication rate [Срок оценки: 90 days]
• comprehensive complication index [Срок оценки: 90 days]
• length of stay [Срок оценки: 90 days]
• intraoperative indicators [Срок оценки: 90 days]

Критерии участия

Критерии включения

• Age between 18 years and 75 years.
• Histologically confirmed PDAC or clinically diagnosed PDAC by an MDT without histopathologic evidence.
• Patients feasible to undergo both LPD and OPD according to MDT evaluations.
• Patients understanding and willing to comply with this trial.
• Provision of written informed consent before patient registration.
• Patients meeting the curative treatment intent in accordance with clinical guidelines.

Критерии исключения

• Patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
• Patients requiring left, central or total pancreatectomy or other palliative surgery.
• Preoperative American Society of Anaesthesiologists (ASA) score ≥ 4.
• History of other malignant disease.
• Pregnant or breast-feeding women.
• Patients with serious mental disorders.
• Patients treated with neoadjuvant therapy.
• Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.
• Body mass index > 35 kg/m2.
• Patients participating in any other clinical trials within 3 months.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical C — Ухань

Публикации

• Wang M, Pan S, Qin T, Xu X, Huang X, Liu J, Chen X, Zhao W, Li J, Liu C, Li D, Liu J, Liu Y, Zhou B, Zhu F, Ji S, Cheng H, Li Z, Li J, Tang Y, Peng X, Yu G, Chen W, Ma H, Xiong Y, Meng L, Lu P, Zhang Z, Yu X, Zhang H, Qin R. Short-Term Outcomes Following Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Pancreatic Ductal Adenocarcinoma: A Randomized Clinical Trial. JAMA Surg. 2023 Dec PMID 37878305
• Pan S, Qin T, Yin T, Yu X, Li J, Liu J, Zhao W, Chen X, Li D, Liu J, Li J, Liu Y, Zhu F, Wang M, Zhang H, Qin R; Minimally Invasive Treatment Group in the Pancreatic Disease Branch of China's International Exchange and Promotion Association for Medicine and Healthcare (MITG-P-CPAM). Laparoscopic versus open pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: study protocol for a multicen PMID 35379633

Идентификаторы

NCT: NCT03785743 · TJDBPS07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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