Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

Interventions

  • Procedure: 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.

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • episodes of postoperative vomiting
    • Time Frame: 6 months after surgery
    • Primary outcomes included episodes of postoperative vomiting in times.
  • major complication
    • Time Frame: 6 months after surgery
    • 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).

Secondary Measures

  • operating and anaesthetic time
    • Time Frame: 6 months after surgery
    • Secondary outcomes included operating and anaesthetic time in minutes.
  • myotomy length
    • Time Frame: 6 months after surgery
    • Secondary outcomes included myotomy length in centimeters
  • other complications
    • Time Frame: 6 months after surgery
    • Secondary outcomes included other complications (yes or no) (eg, mucosal injury, delayed mucosal barrier failure, incomplete pyloromyotomy, and respiratory complications without invasive intervention).
  • postoperative pain assessment by “Pain assessment for children under four years”
    • Time Frame: 6 months after surgery
    • Secondary outcomes included postoperative pain assessment in score. This measurement chart is “Pain assessment for children under four years” which of pain scoring in the postoperative set up is: Cry (yes or no), Posture (relaxed or tense), Expression (relaxed, happy or distressed), Response when spoken to (yes or no). (Gupta A, Kaur K, Sharma S, Goyal S, Arora S, Murthy RS. Clinical aspects of acute post-operative pain management & its assessment. J Adv Pharm Technol Res. 2010;1(2):97-108.)
  • analgesia requirements
    • Time Frame: 6 months after surgery
    • Secondary outcomes included analgesia requirements (yes or no).
  • time to full enteral feed
    • Time Frame: 6 months after surgery
    • Secondary outcomes included time to full enteral feed in hours.
  • postoperative length of stay
    • Time Frame: 6 months after surgery
    • Secondary outcomes included postoperative length of stay in days.
  • need for re-operation
    • Time Frame: 6 months after surgery
    • Secondary outcomes included need for re-operation (yes or no).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 3 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Zhongshan Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pinghong Zhou, Study Chair, Shanghai Zhongshan Hospital
  • Overall Contact(s)
    • Quanlin Li, 64041990, li.quanlin@zs-hospital.sh.cn

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