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Peroral Endoscopic Remyotomy for Failed Heller Myotomy

NCT01637311 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-07-11

No results posted yet for this study

Summary

Achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. With respect to long-term efficacy, Heller myotomy (HM) using an open or a laparoscopic approach has gained wide acceptance as the procedure of choice for the management of patients with primary achalasia in recent years. Although good or excellent long-term symptomatic response rates can be achieved in more than 90% of patients undergoing HM, recurrence or persistence of symptoms occurs in approximately 20%. Controversy exists regarding the therapy of patients with failed success after HM. Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia. Our purpose was to evaluate the efficacy and the feasibility of POEM for patients with failed HM.

Conditions

  • Esophageal Achalasia

Interventions

PROCEDURE

POEM

Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Ping-Hong Zhou, MD,PhD · Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-12-31
Completion
2014-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01637311 on ClinicalTrials.gov