Effect of Celiac Plexus Block on Gastric Emptying and Symptoms Caused by Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Linda Nguyen
- 试验地点
- 1
- 主要终点
- Improvement of gastroparesis based on GCSI-DD score
研究概览
简要总结
The investigators hypothesize that in patients with gastroparesis, gastric emptying will improve with celiac plexus block. By improving gastric emptying, symptoms related to gastroparesis including nausea, vomiting, bloating, abdominal pain, and weight loss, will also improve.
In order to study this hypothesis, the investigators will enroll patients with gastroparesis who are non-responsive to the current treatments available. Patients will fill out a questionnaire to assess the severity of their symptoms then undergo Ansar testing (a non-invasive test) to measure their autonomic function respectively. Then, patients will undergo a celiac plexus block which is performed via an upper endoscopy. One week after the procedure, patients will be asked to undergo a gastric emptying study as well as repeat the Ansar testing to evaluate for any improvement in the gastric emptying and autonomic function respectively. Patient will be asked to repeat the questionnaire, one, two, three, and eight weeks after their procedure.
详细描述
The investigators will identify patients with gastroparesis due to idiopathic causes (including post-viral) and diabetes who have undergone a 4 hour gastric emptying study showing delayed gastric emptying. Patients enrolled must have clinical symptoms due to gastroparesis including nausea, vomiting, abdominal pain, early satiety, bloating, reflux, postprandial fullness or weight loss. Patients included in the study may be refractory to treatment or ineligible for current standard of care with metoclopramide, domperidone, macrolide antibiotics, or pyloric injections with botulinum toxin.
Patients who agree to enroll in the study will sign an informed consent which will explain study purpose along with the risks of the procedures involved in the study. One of the team members will also explain the study to the patient either over the phone or in person and answer any questions they may have in regards to the study.
Patients who are enrolled in the study will fill out a questionnaire comprised of the gastroparesis cardinal symptom index daily diary (GCSI-DD) and visual analog scale (VAS) to assess severity of nausea, vomiting, abdominal pain, and bloating. Then, patients will undergo autonomic function measurements using the Ansar system which is a non-invasive measurement of the autonomic system using blood pressure, heart rate, and respiratory rate monitoring. Ansar testing takes approximately 15 minutes.
Subsequently, patients will undergo a celiac plexus block, performed endoscopically with EUS- guidance by Ann Chen. Injections will be performed using 0.75% bupivicaine and 40mg/ml of triamcinolone, ideally 1ml each directly into the celiac ganglia. If no ganglia is identifiable, then the injection will be performed into the celiac space, located at the take off of the celiac artery from the aorta. One week after their block, a gastric emptying study and Ansar testing will be performed. The GCSI-DD/VAS questionnaire will be repeated 1 week, 2 weeks, 3 weeks, and 2 months after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Patients must have gastroparesis due to idiopathic causes (including post-viral) and diabetes who have undergone a 4 hour gastric emptying study showing delayed gastric emptying
- •Patients may have been or currently on therapy for their gastroparesis including metoclopramide, domperidone, macrolide antibiotics, sapropterin dihydrochloride, or pyloric botox injections can be included
- •Patients who have undergone placement of electrical gastric stimulator >6 months after enrollment can be included
排除标准
- •Patients with suspected mechanical obstruction resulting in delayed gastric emptying, patients chronically using narcotics (>3 times per week)
- •Patients who have undergone placement of gastric electrical stimulation device within 6 months of enrollment.
- •Patients with any history of small bowel obstruction and major abdominal surgeries (excluding appendectomy, cholecystectomy, Nissen fundoplication, or pelvic surgeries).
研究组 & 干预措施
Celiac Plexus Block
There is one treatment arm who undergoes celiac plexus block.
干预措施: Celiac Plexus Block (Procedure)
结局指标
主要结局
Improvement of gastroparesis based on GCSI-DD score
时间窗: 2 months
One, two, three weeks after the procedure as well as 2 months after the celiac plexus block, the patients will fill out a questionnaire questionnaire comprised of the gastroparesis cardinal symptom index daily diary(GCSI-DD).
Increased gastric emptying
时间窗: One week after intervention
We will assess for increased gastric emptying via a SmartPill study, one week after celiac plexus block is performed.
次要结局
- Improvement of individual symptoms related to gastroparesis based on VAS score(1week-2 months after procedure)
研究者
Linda Nguyen
Clinical Assistant Professor
Stanford University