Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis

Fudan University

Status: Unknown

Conditions: Pyloromyotomy; Infantile Hypertrophic Pyloric Stenosis

Treatments: Procedure: G-POEM

Study type: Interventional

Funder types: Other

Identifiers

NCT04148040

ZSLQL

Details and patient eligibility

About

Infantile hypertrophic pyloric stenosis (IHPS) is the most common condition for surgical treatment in infant. Traditionally, laparoscopic or open pyloromyotomy are the standard treatments. However, because of severe dehydration, electrolyte disturbance, and malnutrition, these patients have lower tolerance about surgery and recover more slowly than usual. We are going to study the per-oral pyloromyotomy (POP), also named as gastric per-oral endoscopic myotomy (G-POEM), which showed promising results for adult gastroparesis, for a novel application of treating IHPS.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of pyloric stenosis with or without sonographic confirmation.

Exclusion criteria

• Comorbid conditions that could affect postoperative recovery.
• Needed an additional procedure during the same anaesthetic.

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

G-POEM for infantile hypertrophic pyloric stenosis

Experimental group

Description:

The procedure includes four steps: a) a transversal mucosal incision was performed at the proximal antrum. b) a submucosal longitudinal tunnel was created across the pyloric ring. c) full-thickness pyloromyotomy was performed, with a little extension of the antrum. After pyloromyotomy, an ultrathin gastroscope was used to inspect the mucosa and pyloric outlet. d) after careful hemostasis, the mucosal entry was closed by clips.

Treatment:

Procedure: G-POEM