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临床试验/NCT03117556
NCT03117556撤回不适用

Bilateral Thoracoscopic Splanchnicectomy for Pain Relief in Patients With Unresectable Pancreatic Cancer

University of Louisville4 个研究点 分布在 1 个国家开始时间: 2017年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
4
主要终点
Abdominal pain

研究概览

简要总结

This study aims to compare the efficacy of bilateral thoracoscopic splanchnicectomy (BTS) to conventional narcotic analgesia for control of abdominal pain in patients with pancreatic ductal adenocarcinoma not amenable to surgical resection.

详细描述

All patients with unresectable pancreatic cancer will be considered for participation in this study. Patients with locally advanced or metastatic cancer that meet inclusion criteria will be randomized into one of two arms, treatment with BTS and narcotic analgesia or treatment with narcotic analgesia alone. After randomization a baseline pain score will be assessed using the visual analog pain scale. Narcotic dosage and frequency will be evaluated at the time of enrollment. A pre-treatment quality of life score will be recorded using the SF-12® Patient Questionnaire. Patients will also be queried about the presence of nausea and reflux.

After all baseline assessments are complete patients will be taken to the OR to undergo their assigned procedure. BTS and infusaport placement will be performed on patients randomly selected for treatment with BTS and narcotic analgesia. BTS will be performed as described in the study procedure. Patients chosen to be treated with narcotic analgesia alone will undergo infusaport placement only. An evaluation will be completed postoperatively in which the length of stay, post-op complications, and chest X-ray results will be recorded. Follow-up assessments will be conducted 24-48 hours post-procedure and at the time of discharge. Further follow-up assessments will be conducted 14 days, 30 days, and 90 days post-procedure during an office visit with the clinical research team or medical oncology.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Must be 18 years of age
  • Diagnosed with stage III/IV pancreatic cancer
  • Willing and able to comply with the protocol requirements
  • Able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study

排除标准

  • Participating in another clinical trial for the treatment of cancer at the time of screening
  • Pregnant or currently breast feeding

结局指标

主要结局

Abdominal pain

时间窗: 1 year

Pain will be measured using a visual analog pain score

Daily Narcotic Requirements

时间窗: 1 year

Narcotic usage will be monitored at each follow-up visit

次要结局

  • Presence of Nausea(1 year)
  • Quality of Life Assessment(1 year)
  • Presence of Reflux(1 Year)
  • Use of Anti-emetics(1 year)

研究者

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

Gary C. Vitale, MD

Professor of medicine, General Surgeon

University of Louisville

研究点 (4)

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