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临床试验/NCT02356640
NCT02356640终止2 期

A Randomized Controlled Trial on Endoscopic Ultrasound-guided Celiac Ganglion Neurolysis Versus Percutaneous Celiac Plexus Neurolysis in Patients With Inoperable Cancer

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
3
试验地点
1
主要终点
Pain score measured using the visual analogue scale

研究概览

简要总结

Patients suffering from pancreatic cancer are associated with a poor prognosis and survival of less than one year is expected in inoperable tumours. Management of these patients would be towards palliation of symptoms. Severe pain occurs in 50 to 70% of the patients and this "intractable" pain is often difficult to treat. Different pharmacological agents have been used in the past to control this pain and these include non-steroidal anti-inflammatory drugs and narcotic agents. However, patients' responses are often variable and difficult to predict. Furthermore, these agents are associated with their own adverse effects and may further impair quality of life.

Celiac plexus neurolysis (CPN) was first described in 1919, since then, different approaches of performing the procedure have been described. The standard technique involves a percutaneous approach but CPN can also be performed by an intra-operative approach with open or laparoscopic means. Results from meta-analysis have shown that CPN was associated with superior pain relief as compared to analgesic therapy alone and reduces the need for opioids analgesics in patients with inoperable pancreatic cancer. Furthermore, CPN causes fewer adverse effects than opioid analgesics and it is the preferred method of improving pain relief in these patients.

Recently, endoscopic ultrasonography (EUS) - guided CPN has become popular. The approach is safe and effective and was shown to be associated with long lasting pain relieve in patients suffering from chronic pancreatitis or pancreatic cancer. Serious complications are uncommon and are less than 2% in these series. Transient diarrhoea and hypotension are common after CPN and is seen up to 30% to 40% of the patients, regardless of whether the procedure is being done by the EUS or percutaneous approach. The EUS approach offers several theoretical advantages over the percutaneous option. Most notably is the visualization of the celiac ganglia situated anterior to the aorta, allowing direct injection of the ganglia with alcohol resulting in celiac ganglion neurolysis (CGN). This increases the accuracy of CPN and may result in improved pain control. Furthermore, it could reduce complications associated with the percutaneous approach that includes lower extremity paresthesia and paralysis.

Hence, the aim of the study is to compare the efficacy and safety of endoscopic ultrasound (EUS)-guided celiac ganglion neurolysis (CGN) versus percutaneous celiac plexus neurolysis (CPN) in reducing cancer pain in patients suffering from inoperable cancer. With direct visualization and injection of the celiac ganglion, the investigators hypothesis that EUS-guided CGN is more advantageous on improving pain relief and decreasing the need for opioid analgesics in patients with inoperable cancer as compared to percutaneous CPN.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • All patients ≥ 18 years old with cytology or histology confirmed pancreatic cancer, or radiologically suggestive of pancreatic cancer ( for patients whom biopsy is impossible)
  • Pain associated with inoperable cancer ( including abdominal pain or back pain, managed according to WHO analgesic ladder, with VAS score ≥4 despite simple analgesics (first 2 steps of WHO analgesic ladder)
  • Inoperability of cancer as demonstrated by EUS, computed tomography (CT) or Positive emission tomography
  • Informed consent available

排除标准

  • Unable to safely undergo EUS for any reason
  • Patient is unable to lie prone for procedure
  • Coagulopathy (prolongation of prothrombin time > 18 sec) or thrombocytopenia <80,000 platelets/ml)
  • Previous CPN or other neurolytic block that could affect pancreatic cancer-related pain or had implanted epidural or intrathecal analgesic therapy
  • Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder
  • Allergy to local anaesthesia, contrast, or alcohol
  • Potential patient noncompliance (refusing to follow schedule of events)
  • Active alcohol or other drug use or significant psychiatric illness
  • Expected survival less than 6 weeks

研究组 & 干预措施

EUS-guided celiac ganglion neurolysis

Active Comparator

Endoscopic ultrasound guided celiac ganglion neurolysis would be performed

干预措施: EUS-guided celiac ganglion neurolysis (Procedure)

EUS-guided celiac ganglion neurolysis

Active Comparator

Endoscopic ultrasound guided celiac ganglion neurolysis would be performed

干预措施: Olympus UM 2000 (Device)

Percutaneous celiac plexus neurolysis

Active Comparator

Percutaneous celiac plexus neurolysis would be performed

干预措施: Percutaneous celiac plexus neurolysis (Procedure)

Percutaneous celiac plexus neurolysis

Active Comparator

Percutaneous celiac plexus neurolysis would be performed

干预措施: B-D Quincke Type Point (Device)

Percutaneous celiac plexus neurolysis

Active Comparator

Percutaneous celiac plexus neurolysis would be performed

干预措施: Levobupivacaine (Drug)

结局指标

主要结局

Pain score measured using the visual analogue scale

时间窗: 2 weeks

Pain scores at 2 weeks after the procedure will be measured using the visual analogue scale

次要结局

  • Adverse events(2 weeks, then monthly for 1 yr or till death)
  • Quality of life scores (FACT-Hep Chinese module)(2 week, then monthly for 1 yr or till death)
  • Opioid requirements (Amounts of opioid medications required at assessment interval)(2 weeks then monthly for 1 yr or till death)

研究者

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

Anthony Teoh

Honorary Associate Professor

Chinese University of Hong Kong

研究点 (1)

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