Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis

NCT ID: NCT04148040

Last Updated: 2019-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infantile Hypertrophic Pyloric Stenosis Pyloromyotomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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G-POEM for infantile hypertrophic pyloric stenosis

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.

Group Type EXPERIMENTAL

G-POEM

Intervention Type PROCEDURE

Per-oral pyloromyotomy (POP), also named as gastric per-oral endoscopic myotomy (G-POEM), for treating infantile hypertrophic pyloric stenosis (IHPS) has the following steps: mucosal incision, creation of submucosal tunnel, full-thickness pyloromyotomy, closure of the mucosal entry.

Interventions

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G-POEM

Per-oral pyloromyotomy (POP), also named as gastric per-oral endoscopic myotomy (G-POEM), for treating infantile hypertrophic pyloric stenosis (IHPS) has the following steps: mucosal incision, creation of submucosal tunnel, full-thickness pyloromyotomy, closure of the mucosal entry.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pinghong Zhou

Role: STUDY_CHAIR

Shanghai Zhongshan Hospital

Locations

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Zhongshan hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Quanlin Li

Role: CONTACT

Zuqiang Liu

Role: CONTACT

Facility Contacts

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Quanlin Li

Role: primary

Zuqiang Liu

Role: backup

Other Identifiers

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ZSLQL

Identifier Type: -

Identifier Source: org_study_id

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