Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

Обзор

The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma

Подробное описание

The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma

Вмешательства

• Процедура laparoscopic pancreaticoduodenectomy
  laparoscopic pancreaticoduodenectomy
• Процедура open pancreaticoduodenectomy
  open pancreaticoduodenectomy

Первичные конечные точки

• length of hospital stay [Срок оценки: 90 days]

Вторичные конечные точки (10)

• 1 year OS [Срок оценки: 1 year]
• Operative time [Срок оценки: From enrollment to the end of operation]
• Estimated blood loss [Срок оценки: From enrollment to the end of operation]
• Intraoperative transfusion volume [Срок оценки: From enrollment to the end of operation]
• perioperative complication rate [Срок оценки: 90 days]
• mortality rate and unplanned readmission rate [Срок оценки: 90 days]
• Karnofsky Performance Status (KPS) score [Срок оценки: Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively]
• Eastern Cooperative Oncology Group (ECOG) performance status score [Срок оценки: Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively]
• Surgical costs [Срок оценки: perioperatively]
• Total hospitalization expenses [Срок оценки: perioperatively]

Критерии участия

Критерии включения

• Age between 18 years and 75 years.
• Histologically confirmed NPPC or clinically diagnosed NPPC by an MDT without histopathologic evidence.
• Patients feasible to undergo both LPD and OPD ac- cording 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 ac- cordance with clinical guidelines.

Критерии исключения

• Patients with distant metastases, including peritone- al, liver, distant lymph node metastases and involve- ment of other organs.
• Patients requiring left, central or total pancreatecto- my or other palliative surgery.
• Preoperative American Society of Anaesthesiologists (ASA) score ≥4.
• History of other malignant disease
• Pregnant or breastfeeding 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/m 2 .
• Patients participating in any other clinical trials with- in 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

• Li S, Pan S, Wang M, Huang X, Zhao W, Yu X, Chen X, Chen H, Dang X, Chen G, Wang L, An W, Zhang Q, Gao S, Guo S, Qin T, Zhang H, Qin R. Laparoscopic versus open pancreaticoduodenectomy for non-pancreatic periampullary adenocarcinomas: study protocol for a multicentre randomised controlled trial in China. BMJ Open. 2026 Jul 6;16(7):e117495. doi: 10.1136/bmjopen-2026-117495. PMID 42409398

Идентификаторы

NCT: NCT05788029 · TJDBPS14 · TJDBPS14

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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