Peroral Endoscopic Remyotomy for Failed Heller Myotomy

Fudan University

Status: Unknown

Conditions: Esophageal Achalasia

Treatments: Procedure: POEM

Study type: Interventional

Funder types: Other

Identifiers

NCT01637311

ZSNJ-POEM

Details and patient eligibility

About

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.

Full description

1. Patients were eligible for enrollment in the study if they were age greater than 18 years and had recurrence/persistence of symptoms after primary HM with an Eckardt symptom score ≥ 4. The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy (EGD)). Exclusion criteria were severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk, pseudoachalasia, and megaesophagus (diameter of > 7 cm).
2. All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry. Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires.
3. The primary outcome of the study was therapeutic success (a reduction in the Eckardt score to ≤3) at the follow-up assessment. The secondary outcomes included procedure-related adverse events, LES pressure on manometry pre- and post POEM, reflux symptoms and medication use before and after POEM, and procedure-related parameters such as procedure time, hospital stay, and myotomy length.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than 18 years
• Recurrence/persistence of symptoms after primary HM with an Eckardt symptom score ≥ 4
• The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy)

Exclusion criteria

• Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk
• Pseudoachalasia
• megaesophagus (diameter of > 7 cm)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Failed HM

Experimental group

Description:

Patients were eligible for enrollment in the study if they were age greater than 18 years and had recurrence/persistence of symptoms after primary HM with an Eckardt symptom score ≥ 4.

Treatment:

Procedure: POEM