Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis

NCT04148040 | Unknown

• 1 other identifier: ZSLQL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infantile Hypertrophic Pyloric Stenosis; Pyloromyotomy

Outcome Measures

Primary Outcomes (2)

• episodes of postoperative vomiting

  Primary outcomes included episodes of postoperative vomiting in times.

  6 months after surgery

• major complication

  Primary outcomes included major complication in times (based on lexicon and Clavien-Dindo classification, eg, vital-sign instability, ICU stay, hospital readmission, conversion to laparoscopic or open pyloromyotomy, invasive postoperative procedure, haemorrhage, blood transfusion, or prolonged hospitalization due to functional impairment).

  6 months after surgery

Secondary Outcomes (8)

• operating and anaesthetic time

  6 months after surgery

• myotomy length

  6 months after surgery

• other complications

  6 months after surgery

• postoperative pain assessment by "Pain assessment for children under four years"

  6 months after surgery

• analgesia requirements

  6 months after surgery

Study Arms (1)

G-POEM for infantile hypertrophic pyloric stenosis

EXPERIMENTAL

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.

Procedure: G-POEM

Interventions

G-POEM 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.

G-POEM for infantile hypertrophic pyloric stenosis

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic

Interventions

Pyloromyotomy

Condition Hierarchy (Ancestors)

Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Gastrectomy; Myotomy

Study Officials

• Pinghong Zhou

  Shanghai Zhongshan Hospital

  STUDY CHAIR

Central Study Contacts

Quanlin Li

CONTACT

64041990; li.quanlin@zs-hospital.sh.cn

Zuqiang Liu

CONTACT

64041990; 16111210047@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2019
• First Posted: November 1, 2019
• Study Start: January 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

CN (1)