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临床试验/NCT04911634
NCT04911634Unknown不适用

Laparoscopic Ultrasound Guided Minimal Invasive Excision of Intra-/Retroperitoneal Tumors in Patients Scheduled for Laparotomy: A Pilot Study

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Tumor localization

研究概览

简要总结

Patients included in the study went through standard preoperative preparation and were informed about potential conversion to open surgery. The procedure started with LUS performed according to the department's standard guidelines (one twelve mm trocar in the midline and one 12 mm trocar in the left upper quadrant) followed by a stepwise scanning of relevant structures (e.g. liver, pancreas, retroperitoneum) with dedicated laparoscopic ultrasound equipment (BK Medical, Herlev, Denmark). If the suspected lesion(s) was detected by LUS in the relevant area (according to preoperative imaging), laparoscopic resection was attempted, and if successful the specimen was removed in an eEndo-bBag (Kebomed, Denmark) through one of the trocars. A second LUS was performed to ensure that no tumor was left behind ("loss-of-lesion(s)").

If any problem occurred during the laparoscopic procedure, the operation was converted to an open procedure. Prophylactic antibiotics were not given routinely but were administered during surgery at the surgeons' discretion.

The intra- and postoperative course and final clinical outcome including pathology reports were retrieved from the patient's electronical records. This included a postoperative follow up of at least 12 months to investigate potential incomplete resection. Postoperative complications were graded according to Dindo-Clavien (17). The pathology reports were retrieved from the Danish Pathology Registry.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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 with intra- and retroperitoneal tumor(s) (IRT) detected by imaging (US/CTMR/PET or EUS) and a clinical indication for explorative laparotomy

排除标准

  • Patients with contraindications for laparoscopy, such as severe adherences were excluded

结局指标

主要结局

Tumor localization

时间窗: 12 months

Positive LUS localization of the tumor(s) in minimum 15 patients

LUS guided resection

时间窗: 12 months

A complete LUS guided resection in minimum 15 patients

次要结局

  • Complications(12 months)
  • Final diagnosis(12 months)

研究者

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

Michael Bau Mortensen

Professor, MD, PhD, DMSc

Odense University Hospital

研究点 (1)

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