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临床试验/NCT02314741
NCT02314741已完成不适用

Peroral Endoscopic Myotomy (POEM) for Esophageal Motility in Patients With a Clinical Diagnosis of Achalasia

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Gather Standardized Data on Patients with Achalasia Who Have Been Treated with the POEM Procedure

研究概览

简要总结

The investigators wish to monitor the adoption of a new, incisionless approach to performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally providing similar if not better outcomes (safety and efficacy) as the Heller myotomy. The investigators hope to enroll 10 patients with a clinical diagnosis of achalasia who meet inclusion criteria.

The POEM procedure has been done in many hospitals without any research associated with it. Dr. Ginsberg, Dr. Chandrasekhara and Dr. Kochman will perform the procedures after being trained. Dr. Ginsberg has personally witnessed the performance of 10 POEM procedures and has performed in a swine model. The PI is credentialed to initiate POEM at HUP with the first case to be proctored by an experienced operator. The PI will then proctor the other adopters. The investigators would like to evaluate the safety of it and the effectiveness of it. The investigators will use their symptom scores and radiology tests pre- and post-POEM to evaluate effectiveness.

详细描述

An esophageal motility disorder is when muscular contractions become discoordinated or weak and interfere with movement of food down the esophagus. Some esophageal motility disorders persist long enough to cause severe problems requiring surgical intervention. Achalasia, one subtype of esophageal motility disorder that is a rare disease, can be defined by the esophageal sphincter and muscle unable to relax or dilate. Left untreated, symptoms such as difficulty swallowing, regurgitation, heartburn, and chest pain may easily turn into complications such as severe weight loss, malnutrition, coughing, pulmonary infection, pneumonia, and perforation of the esophagus. Diagnosis of esophageal achalasia can be determined by esophageal manometry and/or barium swallow esophagram. Treatment for achalasia includes balloon dilation, botulinum toxin injection and surgical intervention. Balloon dilation is performed by inserting a balloon through the esophageal sphincter, inflating the balloon, disrupting the esophageal muscle. Botox has also been known to successfully relax spastic muscle contractions of achalasia through direct injection into the esophageal muscle. Unfortunately, each alternative to surgical treatment often requires repeated administration to improve the symptoms of achalasia. Traditional treatment of achalasia has included open abdominal or thoracic surgical procedures to cut valve muscles between the esophagus and stomach (Heller Myotomy). Laparoscopic multi-port Heller myotomies have become the preferred approach, requiring 4 smaller abdominal incisions for placement of laparoscope equipment. Results of this laparoscopic technique have proven that although 2/3 of the patient population was successfully treated, a subset of this group still need repeat surgical procedures or balloon dilation. Recently, single-incision laparoscopic Heller myotomies have produced favorable results, with a single umbilical incision preferential to multiple-incision laparoscopy. We propose adoption of a new, incisionless approach to performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic Myotomy (POEM) is expected to provide a less-invasive treatment for esophageal achalasia, ideally providing similar if not better outcomes as the Heller myotomy and can be adopted safely and effectively at Penn Medicine.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > or = to 18 years of age
  • Clinical diagnosis of achalasia
  • A candidate for Heller myotomy
  • Esophageal manometry and barium esophogram with findings supportive of achalasia diagnosis
  • Women of childbearing potential: negative urine pregnancy test
  • Able to undergo general anesthesia
  • Willing and able to give informed consent

排除标准

  • < 18 years of age
  • Pregnancy
  • Previous mediastinal or esophageal surgery
  • Contraindications for esophagogastroduodenoscopy
  • Presence of malignancy
  • Coagulopathy (INR 1.5)
  • Thrombocytopenia (platelet count < 100K/microliter)
  • ASA Score > Class II
  • History of mental illness
  • Any medical conditions as determined by the PI to be a contraindication to the procedure
  • Unable to give informed consent

研究组 & 干预措施

POEM Treatment Arm

Experimental

Patients treated with the POEM (per-oral endoscopic myotomy) procedure.

干预措施: POEM Procedure (Procedure)

结局指标

主要结局

Gather Standardized Data on Patients with Achalasia Who Have Been Treated with the POEM Procedure

时间窗: About 12 months

The primary aim of this study is to assess safety and efficacy in the adoption of the POEM procedure compared to the typical Heller Myotomy used for the treatment of achalasia using standardized methods, including esophageal manometry, pre- and post- procedure barium swallow studies, as well as standardized measures of dysphagia symptoms due to achalasia (the Eckart score), and patient's medical records and self-reported symptoms.

次要结局

  • Pre-Procedure versus Post-Procedure Barium Swallow Results in POEM Patients(About 6 Months)
  • Pre-Procedure Versus Post-Procedure Eckart Score Results in POEM Patients(About 6 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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