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Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis

Primary Purpose

Infantile Hypertrophic Pyloric Stenosis, Pyloromyotomy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
G-POEM
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Hypertrophic Pyloric Stenosis

Eligibility Criteria

undefined - 3 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Zhongshan hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

G-POEM for infantile hypertrophic pyloric stenosis

Arm 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.

Outcomes

Primary Outcome Measures

episodes of postoperative vomiting
Primary outcomes included episodes of postoperative vomiting in times.
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).

Secondary Outcome Measures

operating and anaesthetic time
Secondary outcomes included operating and anaesthetic time in minutes.
myotomy length
Secondary outcomes included myotomy length in centimeters
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).
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.)
analgesia requirements
Secondary outcomes included analgesia requirements (yes or no).
time to full enteral feed
Secondary outcomes included time to full enteral feed in hours.
postoperative length of stay
Secondary outcomes included postoperative length of stay in days.
need for re-operation
Secondary outcomes included need for re-operation (yes or no).

Full Information

First Posted
October 12, 2019
Last Updated
November 12, 2019
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04148040
Brief Title
Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis
Official Title
Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Hypertrophic Pyloric Stenosis, Pyloromyotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
G-POEM for infantile hypertrophic pyloric stenosis
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
G-POEM
Intervention Description
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.
Primary Outcome Measure Information:
Title
episodes of postoperative vomiting
Description
Primary outcomes included episodes of postoperative vomiting in times.
Time Frame
6 months after surgery
Title
major complication
Description
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).
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
operating and anaesthetic time
Description
Secondary outcomes included operating and anaesthetic time in minutes.
Time Frame
6 months after surgery
Title
myotomy length
Description
Secondary outcomes included myotomy length in centimeters
Time Frame
6 months after surgery
Title
other complications
Description
Secondary outcomes included other complications (yes or no) (eg, mucosal injury, delayed mucosal barrier failure, incomplete pyloromyotomy, and respiratory complications without invasive intervention).
Time Frame
6 months after surgery
Title
postoperative pain assessment by "Pain assessment for children under four years"
Description
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.)
Time Frame
6 months after surgery
Title
analgesia requirements
Description
Secondary outcomes included analgesia requirements (yes or no).
Time Frame
6 months after surgery
Title
time to full enteral feed
Description
Secondary outcomes included time to full enteral feed in hours.
Time Frame
6 months after surgery
Title
postoperative length of stay
Description
Secondary outcomes included postoperative length of stay in days.
Time Frame
6 months after surgery
Title
need for re-operation
Description
Secondary outcomes included need for re-operation (yes or no).
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quanlin Li
Phone
64041990
Email
li.quanlin@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zuqiang Liu
Phone
64041990
Email
16111210047@fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pinghong Zhou
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quanlin Li
Phone
64041990
Email
li.quanlin@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Zuqiang Liu
Phone
64041990
Email
16111210047@fudan.edu.cn

12. IPD Sharing Statement

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Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis

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