Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis

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 Overview

• Status: Unknown
• Conditions: Infantile Hypertrophic Pyloric Stenosis; Pyloromyotomy
• Intervention / Treatment: Procedure: G-POEM

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Zhongshan Hospital
    • Contact: Quanlin Li; Phone Number: 64041990; Email: li.quanlin@zs-hospital.sh.cn
    • Contact: Zuqiang Liu; Phone Number: 64041990; Email: 16111210047@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
operating and anaesthetic time	Secondary outcomes included operating and anaesthetic time in minutes.	6 months after surgery
myotomy length	Secondary outcomes included myotomy length in centimeters	6 months after surgery
other complications	Secondary outcomes included other complications (yes or no) (eg, mucosal injury, delayed mucosal barrier failure, incomplete pyloromyotomy, and respiratory complications without invasive intervention).	6 months after surgery
postoperative pain assessment by "Pain assessment for children under four years"	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.)	6 months after surgery
analgesia requirements	Secondary outcomes included analgesia requirements (yes or no).	6 months after surgery
time to full enteral feed	Secondary outcomes included time to full enteral feed in hours.	6 months after surgery
postoperative length of stay	Secondary outcomes included postoperative length of stay in days.	6 months after surgery
need for re-operation	Secondary outcomes included need for re-operation (yes or no).	6 months after surgery

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Pinghong Zhou, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 12, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathological Conditions, Anatomical; Hypertrophy; Constriction, Pathologic; Pyloric Stenosis; Gastric Outlet Obstruction; Pyloric Stenosis, Hypertrophic
• Other Study ID Numbers: ZSLQL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No