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Evaluation of Injection Techniques in Celiac Plexus Neurolysis

2016年4月12日 更新者：AdventHealth

Evaluation of Injection Techniques in Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN)

1. To evaluate the efficacy of EUS-CPN in subjects who experience a sympathetic response during injection when compared with subjects who do not experience sympathetic response during injection.

EUS-CPN when performed in subjects who experience a sympathetic response during injection will have better pain relief when compared to subjects who do not experience a sympathetic response during injection.

研究概览

地位

完全的

条件

干预/治疗

详细说明

  1. All adult patients with radiologically consistent pancreatic carcinoma referred to Florida Hospital to undergo EUS for staging and diagnostic FNA of pancreatic mass lesions will be eligible for study entry.

    A history and physical examination will be performed to determine the character and quality of the pain and to evaluate for any contraindication for which EUS cannot be performed.

  2. Written informed consent for study participation will be obtained at the same time as the consent for the procedure as this study is comparing standard of care treatment options in a regular treatment setting. Then, after giving written informed consents and prior to the index procedure, all patients will complete the following written assessments:

    1. Standardized 11-point continuous visual analog pain scale (12)
    2. Quality of life instruments: Functional Assessment of Cancer Therapy, Pancreatic Cancer (FACT-PA) (i.e. QLQ-30 and PAN-26) (13)
    3. Pain medication usage over prior 2 days (converted to equianalgesic doses of morphine)
  3. EUS will be performed in standard fashion by one of three experienced endoscopists

  4. Eligible patients will be included if pancreatic carcinoma is confirmed by FNA performed during EUS and if EUS or CT staging shows unresectability of the tumor. Cytology evaluation of FNA is routinely provided during procedure by pathologist into the endoscopy room at our institution.

    During EUS, included patients will receive CPN in the standard fashion. Whether a sympathetic response occurs or not during CPN, this will be documented. Sympathetic response will be defined as change in heart rate by >10 bpm and change in BP <10mmHg. The technique of EUS-CPN is as follows:

    • Using a curvilinear array echoendosocpe, the region of the celiac plexus is visualized from the lesser curvature of the stomach by following the aorta to the origin of the main celiac artery. It is traced, by using counter-clockwise rotation, to its bifurcation into splenic and hepatic arteries, with Doppler US control if needed.
    • CPN will be undertaken at the celiac space which is located between the aorta and the celiac artery origin.
    • A 20-gauge fenestrated CPN needle is used, its tip is placed slightly anterior and cephalic to the origin of the celiac artery.
    • Aspiration is first performed to ensure that vascular puncture has not occurred.
    • Bupivacaine is injected first, followed by alcohol.
    • Patients will be observed for 2 to 4 hours, with careful monitoring of pulse, blood pressure and temperature.
  5. Following EUS, patients will be discharged and called at home by research nurse at 24 hours for evidence of pancreatitis or other complications from the procedure, Clinical research nurse* will also contact the patient at 1, 2, 4 weeks after EUS and then monthly until death or 1 year. Clinical research nurse* will be blinded to the documentation about sympathetic response. Assessment of pain scale, QOL, medication use and side effects will be performed.
  6. Following CPN, EUS operator will not be actively involved in patient care.
  7. Medical decisions for each patient will be made by the patient's primary physician and oncologist.
  8. Patient can be referred for rescue CPN if the patient's primary physician and oncologist feel that this is warranted.

研究类型

介入性

注册 (实际的)

51

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。

学习地点

  • 美国
    • Florida
      • Orlando、Florida、美国、32803
        • Florida Hospital

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

19年 至 89年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Abdominal pain typical for pancreatic cancer ( pain score ≥ 3/10)
  2. Abdominal CT consistent with diagnosis of pancreatic cancer
  3. Pancreatic cancer confirmed by EUS-FNA
  4. Inoperable pancreatic cancer as determined during EUS or prior CT

Exclusion Criteria:

  1. Age under 19 years
  2. Unable to safely undergo EUS for any reason
  3. Coagulopathy (Prothrombin time > 18 secs, platelet count < 80,000/ml)
  4. Previous CPN or other neurolytic block that could affect pancreatic cancer-related pain or had implanted epidural or intrathecal analgesic therapy
  5. Another cause for abdominal pain such as pseudocyst, ulcer or other intrabdominal disorder
  6. Noncompliance such that the patient would not return for subsequent follow-up
  7. Active alcohol or other drug use or significant psychiatric illness
  8. Unable to consent
  9. Non-English speaking

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

  • 分配：非随机化
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：sympathetic response
This group will be composed of subjects who experience a heart rate and/or Blood Pressure change during injection.
其他：Sympathetic response
Sympathetic response will be defined as change in heart rate by >10 bpm and change in BP <10mmHg.
其他：no sympathetic response
This group will be made up of subjects that do not experience a vital sign change with injection for CPN.
其他：no sympathetic response
no Sympathetic response will be defined as change in heart rate by <10 bpm and change in BP <10mmHg.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
abdominal pain
大体时间：within the first year post CPN

The primary endpoint of the study is abdominal pain. It will be assessed with a standardized 11-point continuous visual analog pain scale with "0" equaling no pain, "5" moderate pain and "10" worst pain ever. Before the procedure, patient will be instructed in the use of the pain scale by the research nurse. After the procedure, pain scores will be assessed by the clinical research nurse at the predetermined intervals.

A complete response will be defined as an absence of abdominal pain requiring no pain medications. A partial response will be defined as a greater than 50% reduction in abdominal pain as assessed by the numerical 0-10 pain score.

Failure will be defined as a reduction of ≤20% in pain score.
within the first year post CPN

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

AdventHealth

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

2013年8月1日

初级完成 (实际的)

2014年11月1日

研究完成 (实际的)

2014年11月1日

研究注册日期

首次提交

2013年8月30日

首先提交符合 QC 标准的

2014年2月19日

首次发布 (估计)

2014年2月21日

研究记录更新

最后更新发布 (估计)

2016年4月14日

上次提交的符合 QC 标准的更新

2016年4月12日

最后验证

2016年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 456550

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

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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