Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure

NCT ID: NCT01873300

Last Updated: 2015-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-08-31

Brief Summary

Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions (belly area cuts), by using an endoscope to create a small cut at the most inner layer of the esophagus to expose the esophageal sphincter muscle fibers from the inside of the esophagus. The investigators are studying whether subjects who undergo Endoscopic Esophageal Myotomy will have similar functional outcome, and at the same time less pain, scar formation and wound infection than with laparoscopic or open surgery.

Detailed Description

The purpose of this research study is to find out more about a less invasive way of doing the surgical procedure (esophageal myotomy) to treat Achalasia.

Achalasia is a disease of the esophagus, where the lower esophageal sphincter fails to relax, causing difficulty in swallowing.

Esophageal myotomy (Heller myotomy) is surgically cutting the muscle fibers of the esophageal sphincter to allow passage of food into the stomach.

Esophageal myotomy is routinely done either by laparoscopic or open surgery. Laparoscopic surgery requires several (about 4 to 5) small incisions in the abdomen to allow the camera and surgical instruments to be introduced into the abdominal cavity to perform the myotomy. In open surgery, a 6- to 8-inch abdominal incision is made to gain access to the abdominal cavity to perform the myotomy.

Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions.

The researchers are investigating how safe Endoscopic Esophageal Myotomy is and how well it works. Additionally, the researchers will assess the level of pain and the amount of scarring subjects has after this surgery.

Conditions

Achalasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment group

Patients undergoing POEM procedure

Group Type: EXPERIMENTAL

Endoscopic Esophageal Myotomy

Intervention Type: PROCEDURE

Endoscopic mucosotomy, with submucosal tunneling and circular muscular fiber myotomy and mucosa closure.

Interventions

Endoscopic Esophageal Myotomy

Endoscopic mucosotomy, with submucosal tunneling and circular muscular fiber myotomy and mucosa closure.

Intervention Type: PROCEDURE

Other Intervention Names

POEM; Trans-esophageal endoscopic myotomy; Per-oral endoscopic myotomy; Endoscopic Heller Myotomy

Eligibility Criteria

Inclusion Criteria

• Diagnosis of achalasia
• Age 18-65
• ASA class 1-2

Exclusion Criteria

• Pregnant women
• Any prior surgical or endoscopic treatment for achalasia except dilation less than 20 mm
• Patients who are taking immunosuppressive medications or are immunocompromised Patients on blood thinners or aspirin or with history of bleeding disorders
• ASA class III patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

David W. Rattner, MD

Professor of Surgery - Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David W Rattner, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Ozanan R Meireles, MD

Role: STUDY_DIRECTOR

Masschusetts General Hospital / Harvard Medical School

Locations

Masschusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Inoue H, Kudo SE. [Per-oral endoscopic myotomy (POEM) for 43 consecutive cases of esophageal achalasia]. Nihon Rinsho. 2010 Sep;68(9):1749-52. Japanese.

Reference Type: BACKGROUND

PMID: 20845759 (View on PubMed)

Inoue H, Tianle KM, Ikeda H, Hosoya T, Onimaru M, Yoshida A, Minami H, Kudo SE. Peroral endoscopic myotomy for esophageal achalasia: technique, indication, and outcomes. Thorac Surg Clin. 2011 Nov;21(4):519-25. doi: 10.1016/j.thorsurg.2011.08.005.

Reference Type: BACKGROUND

PMID: 22040634 (View on PubMed)

von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.

Reference Type: BACKGROUND

PMID: 22068665 (View on PubMed)

Other Identifiers

2011P001806

Identifier Type: -

Identifier Source: org_study_id