Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

Fudan University

Status: Unknown

Conditions: Esophageal Achalasia

Treatments: Procedure: Conventional POEM; Procedure: Water-jet POEM

Study type: Interventional

Funder types: Other

Identifiers

NCT01742494

Hybrid POEM

Details and patient eligibility

About

Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.

Full description

Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C).

Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).

Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)
• Informed patient consent was obtained

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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Water-jet POEM

Active Comparator group

Description:

POEM were performed by the use of Erbe Hybrid knife (WJ group)

Treatment:

Procedure: Water-jet POEM

Conventional POEM

Active Comparator group

Description:

POEM were performed by the conventional technique using injection and triangle tip knife (C group).

Treatment:

Procedure: Conventional POEM