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临床试验/NCT05670574
NCT05670574招募中不适用

Surgery With Extended (D3) Mesenterectomy for Small Bowel Tumors

Sykehuset i Vestfold HF2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
Number of lymph nodes in total in D2 and D3 areas

研究概览

简要总结

The study is designed to investigate the safety and efficacy of central D3 lymphadenectomy in cases of small bowel tumors. Such dissection is under debate; consensus guidelines are vague when it comes to surgical techniques and practice is highly variable.

详细描述

Cancer of the small intestine is rare. Consensus practice on surgical technique have been difficult to reach, both on lymph node dissection level and on strategic choices according to tumor localization and -type. Evidence is strong for systematic and radical lymphadenectomy for neuroendocrine tumors (NET) and adenocarcinomas. This study includes a series of prospective and consecutive patients operated with central (D3) lymphadenectomy. Key points are preoperative mapping of vascular anatomy to facilitate personalized surgery with radical lymphadenectomy to the mesenterial root, both anterior and posterior to the superior mesenteric vessels. Three different surgical techniques (plus one subgroup) are used, and will be reported on, according to tumor localization and -type. Complications, perioperative morbidity and mortality, operating time and length of hospital stay will be noted, as well as tumor types, number of tumors, mesenteric mass size, resection types and margins, and the anatomical distribution of tumors. Patient outcome during 2- and 5-year follow up will be reported. We will investigate the accuracy of the preoperative vascular anatomy reconstructions and eventual procedure-specific complications. Still, the main outcome measures are the lymph node yield: number of lymph nodes gained in the D2 and D3 areas.

Patients are included in the study "Safe extended (D3) mesenterectomy for small bowel tumors" - REK number 19898. Patients are given an informed consent formula. Inclusion criteria are patients with small bowel tumor(s) of probable or confirmed neoplastic nature capable of consent and without general inoperability properties. The ENETS Neuroendocrine Tumor Centre of Excellence at Oslo University Hospital approves and recommends surgery for patients with NET. All patients shall have their mesenterial vascular anatomy reconstructed in 3D preoperatively, for both arteries and veins. The reconstruction is made by manual segmentation based on biphasic CT scans of their abdomens.

The surgical-oncological aim is the same for both open and minimally invasive access surgery: an intact and continuous specimen with tumor and mesentery in one piece including unbroken and correct anatomical tissue planes. We define the D3 volume to include all lipolymphatic tissue anterior and posterior to the superior mesenteric vessels limited by arterial and venous branches to and from the tumor-bearing segment of bowel. Dissection is made along the blood vessels cranially and caudally. Mesenteric nodal masses and fibrosis and desmoplasia are carefully dissected from the underlying blood vessels to be saved by exposing and dividing the vessel sheets

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients included must be able to fill in an informed, written consent and to understand its implications and contents and to participate in the follow-up
  • Radiologically/scintigraphically/histologically verified extraduodenal tumor(-s) in the small bowel and/or in the mesentery of the small bowel
  • No signs of inoperability
  • Fit for general anesthetics

排除标准

  • Extraduodenal small bowel tumors verified as GIST or benign tumor
  • Widespread lymphoma

结局指标

主要结局

Number of lymph nodes in total in D2 and D3 areas

时间窗: 1 month

Number of positive lymph nodes in D2 and D3 areas

时间窗: 1 month

次要结局

  • Operation time(Intraoperative)
  • 2-year follow-up(2 years)
  • Peroperative blood loss(30 days)
  • Tumor type(30 days)
  • Presence and size of mesenteric mass(30 days)
  • Resection type and -margins(30 days)
  • Complications(30 days)
  • 30-day mortality(30 days)
  • 5-year follow-up(5 years)
  • Hospitalization time(1-90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dejan Ignjatovic

Professor

University Hospital, Akershus

研究点 (2)

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