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临床试验/NCT03670992
NCT03670992已完成不适用

Case Series: Combined, Surgical-only Treatment of Pancreatic and Extra-pancreatic Metastases From Renal Cell Carcinoma - a Quality of Life and Survival Analysis

Azienda Policlinico Umberto I1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2016年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Survival

研究概览

简要总结

Data from 26 patients undergoing resection of Pancreatic Metastases and extra-Pancreatic Metastases from RCC were retrospectively analysed. Clinical data were collected from a digital database and QoL was assessed through patient's interview and Karnofsky performance scale.

详细描述

Retrospective data was analysed from 26 patients that were submitted to pancreatic resection between August 2002 and November 2015. Inclusion criteria were: single or multiple metastases in pancreas or extra pancreatic; primary RCC; never received chemotherapic treatment; patients that already received a previous pancreatic resection were also included.

Cases were collected from two high-volume centres: Surgical Department "Pietro Valdoni" in Policlinico Umberto I and the Division of Transplantation and General Surgery at University of Pisa.

Different kind of surgical approaches were taken into account in this study: duodenal-pancreatectomy, total-pancreatectomy and distal-pancreatectomy associated or not with other metastatic site resections. Surgery was performed either with classical open approach and modern robotic surgical approach, with the robot "Da Vinci". Aim of surgical interventions were to remove all metastases in association to radical lymphadenectomy thus to achieve R0 result. All postoperative events occurring within 90 days of surgery were considered. Postoperative complications were graded according to Clavien-Dindo classification.

Patients were followed-up 3 months after discharge and every 6 months thereafter.

Patients had blood chemistries and CT scans at least every year. A database was used to record all patients' data. Results were analysed in terms of Operative Mortality and Morbidity, Actuarial Survival, Actuarial Disease-Free Survival and Quality of Life.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • metastases from RCC
  • surgically manageable lesions

排除标准

  • metastases from different malignancies
  • other malignancies
  • surgically unmanageable

结局指标

主要结局

Survival

时间窗: follow up 36 months

Three years survival

Survival 3

时间窗: follow up 120 months

ten years Survival

Survival 2

时间窗: follow up 60 months

five years survival

次要结局

  • Nutritional status(mean follow up 45 months range (6-163 months))
  • Serum albumin(mean follow up 45 months range (6-163 months))
  • Hemoglobin(mean follow up 45 months range (6-163 months))
  • Karnofsky scale(mean follow up 45 months range (6-163 months))
  • Activity of daily living scale (ADL scale)(mean follow up 45 months range (6-163 months))
  • Instrumental Activity of daily living scale (IADL scale)(mean follow up 45 months range (6-163 months))

研究者

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

Professor Stefania Brozzetti

Professor

Azienda Policlinico Umberto I

研究点 (1)

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