Peroral Endoscopic Myotomy (POEM) for Esophageal Motility

NCT02314741 | Completed

• 1 other identifier: 819130
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Achalasia

Keywords

poem; per oral endoscopic myotomy; achalasia

Outcome Measures

Primary Outcomes (1)

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

  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.

  About 12 months

Secondary Outcomes (2)

• 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

Study Arms (1)

POEM Treatment Arm

EXPERIMENTAL

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

Procedure: POEM Procedure

Interventions

POEM Procedure PROCEDURE

The procedure is performed under anesthesia.The procedure involves endoscopic electrosurgical dissection with an Olympus triangular tip knife.The myotomy is usually \~6cm long \& averages 8-10cm. After the myotomy is performed the scope is withdrawn \& inserted into the lumen to inspect the mucosa, ensure mucosal integrity \& confirm easy passage of the endoscope through the LES consistent with an adequate myotomy. The mucosal entry site is usually 2-3cm long, \& is closed with 5-10 endoscopic clips. Patients are hospitalized after procedure for observation.The patient is given IV-nutrition until post-operative day 1. An esophagram is obtained. If no loss of mucosal integrity or leak is noted, a liquid diet is started, which is continued for several days before initiating a solid diet.

Also known as: POEM, per oral endoscopic myotomy

POEM Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

Pyloromyotomy

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Gastrectomy; Myotomy

Study Officials

• Vinay Chandrasekhara, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Gregory G Ginsberg, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Gary W Falk, MD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Michael Kochman, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• David C Metz, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: December 11, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

US (1)