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Modified Single-Incision Plus One-Port Versus Conventional Five-Port Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

2026年8月2日 更新者：Nanfang Hospital, Southern Medical University

Modified "Single-Incision Plus One "Versus Conventional "Five-Port" Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas: Study Protocol for A Multicentre Randomised Controlled Trial

This multicenter, randomized, controlled, non-inferiority trial will compare modified single-incision plus one-port laparoscopic pancreaticoduodenectomy (mSILPD+1) with conventional five-port laparoscopic pancreaticoduodenectomy (CLPD) in adults with histologically confirmed or highly suspected non-pancreatic periampullary carcinoma who are candidates for pancreaticoduodenectomy. A total of 232 participants will be randomly assigned in a 1:1 ratio. Outcome assessors who adjudicate complications and interpret imaging will be masked to treatment assignment. The primary outcomes are all-cause mortality within 90 days after surgery and overall survival at 1 year after surgery. Secondary outcomes will assess postoperative complications, surgical performance, postoperative recovery, disease-free survival, quality of life, and health-care costs.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

232

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国
        • 招聘中
        • The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
        • 接触：
    • Guangdong
      • Guangzhou、Guangdong、中国、510515
        • 招聘中
        • Nanfang Hospital, Southern Medical University
        • 接触：
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • 招聘中
        • West China Hospital, Sichuan University
        • 接触：
      • Jiancheng、Sichuan、中国、641400
        • 招聘中
        • The People's Hospital of Jianyang City
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age 18 years or older and younger than 75 years.
  • Histopathologically confirmed non-pancreatic periampullary carcinoma, or a high clinical suspicion of non-pancreatic periampullary carcinoma when preoperative pathological confirmation is unavailable.
  • Determined by preoperative multidisciplinary team evaluation to require pancreaticoduodenectomy.
  • Able to understand and comply with study procedures.
  • Able and willing to provide written informed consent before any study-specific screening procedure.
  • Expected to benefit from therapeutic pancreaticoduodenectomy according to applicable clinical guidelines.

Exclusion Criteria:

  • Distant metastasis, including peritoneal, hepatic, distant lymph node, or other organ metastasis.
  • Requirement for distal, central, or total pancreatectomy, or another palliative procedure.
  • Preoperative American Society of Anesthesiologists physical status classification of 4 or higher.
  • Concurrent malignancy other than the target cancer.
  • Pregnancy or breastfeeding.
  • Severe psychiatric disorder that would interfere with study participation.
  • Receipt of neoadjuvant chemotherapy or radiotherapy before surgery.
  • Vascular invasion requiring vascular resection, as determined by the multidisciplinary team based on preoperative abdominal imaging.
  • Body mass index greater than 35 kg/m².
  • Participation in another clinical trial within the previous 3 months.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Modified Single-Incision Plus One-Port Laparoscopic Pancreaticoduodenectomy
程序：Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy
A pancreaticoduodenectomy performed through a 60- to 80-mm periumbilical single-incision access platform containing three trocars, with one additional 12-mm laparoscopic port. Resection and reconstruction are performed according to the standardized multicenter operative protocol.
其他名称：
  • mSILPD+1
有源比较器：Conventional Five-Port Laparoscopic Pancreaticoduodenectomy
Patients undergo conventional five-port laparoscopic pancreaticoduodenectomy. Standard laparoscopic technique with five abdominal trocars is adopted for pancreaticoduodenectomy and digestive tract reconstruction.
程序：Conventional Laparoscopic Pancreaticoduodenectomy
A conventional laparoscopic pancreaticoduodenectomy performed using five trocar ports, followed by resection and reconstruction according to the standardized multicenter operative protocol.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Overall Survival Rate at 1 Year After Surgery
大体时间：From the date of surgery to 1 year after surgery
From the date of surgery to 1 year after surgery
All-Cause Mortality Within 90 Days After Surgery
大体时间：From surgery through 90 days after surgery
From surgery through 90 days after surgery

次要结果测量

结果测量
措施说明
大体时间
Overall Postoperative Complication Rate Within 30 Days
大体时间：From surgery through 30 days after surgery
From surgery through 30 days after surgery
R0 Resection Rate
大体时间：At final postoperative pathological assessment, up to 30 days after surgery
R0 resection rate, defined as the percentage of subjects without microscopic residual tumor on surgical margins based on final postoperative pathological assessment.
At final postoperative pathological assessment, up to 30 days after surgery
Operative Time
大体时间：During the index surgery
During the index surgery
Disease-Free Survival Rate at 1 Year After Surgery
大体时间：From the date of surgery to 1 year after surgery
From the date of surgery to 1 year after surgery
Conversion to Open Surgery Rate
大体时间：During the index surgery
During the index surgery
Postoperative Length of Hospital Stay
大体时间：From surgery to hospital discharge, up to 30 days after surgery
Duration of hospitalization from the date of surgery until hospital discharge, reported as number of days.
From surgery to hospital discharge, up to 30 days after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nanfang Hospital, Southern Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月4日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2029年12月1日

研究注册日期

首次提交

2026年7月27日

首先提交符合 QC 标准的

2026年8月2日

首次发布 (实际的)

2026年8月4日

研究记录更新

最后更新发布 (实际的)

2026年8月4日

上次提交的符合 QC 标准的更新

2026年8月2日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • NFEC-2026-403

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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