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临床试验/NCT04403074
NCT04403074招募中不适用

Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis, Database Repository

Indiana University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2017年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
35
试验地点
1
主要终点
Dosage of pain medication

研究概览

简要总结

Physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound pain management for patients with chronic pancreatitis.

详细描述

Chronic pancreatitis is extremely painful and pain management in patients with chronic pancreatitis is challenging. The etiology of abdominal pain in chronic pancreatitis is considered multifactorial. Current treatments for pain control primarily include narcotic & opioid administration; however, these medications require titration of dosage for optimal pain control and are frequently followed by adverse effects such as constipation, nausea or drug addiction. Currently, the FDA has imposed strict regulations regarding the amount, frequency & length of time patients may receive these medications. With tightly controlled regulations for prescribing narcotics and opioids for chronic pain management, the epidemic of street drug usage and overdose has dramatically increased. Alternatively, celiac plexus block and celiac plexus neurolysis performed under EUS guidance have been employed for pain control for at least 2 decades and deemed safe. Celiac plexus block refers to temporary inhibition of nerves of the celiac plexus, by using a combination of steroid and numbing medications injected into the celiac plexus ganglia. Celiac plexus neurolysis (CPN) refers to a temporary to semi-permanent inhibition of nerves of the celiac plexus ganglia. Injection of alcohol as a neurolytic agent is used in place of the steroid which causes neurolysis of the celiac plexus or ganglia.

This study will focus on collecting data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically for the management of chronic pancreatitis pain. This data will be used for research purposes to determine the clinical impact of EUS-CPN management in chronic pancreatitis pain. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved patient management.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • 18 years of age or older
  • Referral for the treatment of pain related to chronic pancreatitis

排除标准

  • Less than 18 years of age
  • Absence of chronic pancreatitis

研究组 & 干预措施

Chronic Pancreatitis Patients

Patients that have Chronic Pancreatitis and the current treatment with Celiac Plexus Blocks (CPB) are providing minimal relief of pain (CPB provide less than one month of pain relief). These patient will then receive a Celiac Plexus Neurolysis.

干预措施: Celiac Plexus Neurolysis (Procedure)

结局指标

主要结局

Dosage of pain medication

时间窗: Immediately post procedure and weekly up to 24 weeks

Compare dose of pain medication post procedure \& weekly for up to 24 weeks after converting all to morphine equivalents

Use of Pain medication

时间窗: Immediately post procedure & weekly up to 24 weeks

Use of pain medication (by using morphine equivalents) for each patient will be tracked weekly for up to 24 weeks post CPN to track pain management/relief for the of patients. There should be a lessening in use of pain medication as time progesses.

Patient's pain intensity score (numeric pain rating scale using the visual analogue scale VAS from 1-10) will be assessed weekly (via phone call follow ups) starting right after CPN and continuing for 24 weeks.

时间窗: Immediately post procedure and weekly up to 24 weeks

Compare weekly pain intensity score for pain management/relief of patients.

次要结局

未报告次要终点

研究者

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

Mohammad Al-Haddad

Associate Professor of Medicine, Associate Clinical Director

Indiana University

研究点 (1)

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