Infantile Hypertrophic Pyloric StenosisNCT04148040
Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis
A study testing G-POEM in people with Infantile Hypertrophic Pyloric Stenosis and Pyloromyotomy, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Infantile Hypertrophic Pyloric Stenosis, Pyloromyotomy
- What is being tested?
- G-POEM
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of pyloric stenosis with or without sonographic confirmation.
Who cannot join
- Comorbid conditions that could affect postoperative recovery.
- Needed an additional procedure during the same anaesthetic.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital
Shanghai
Quanlin Li, 64041990, li.quanlin@zs-hospital.sh.cn
Zuqiang Liu, 64041990, 16111210047@fudan.edu.cn
About this study
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.
- Being tested
- G-POEM
- Medical subject headings
- Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-POEMProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: G-POEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
episodes of postoperative vomiting
Primary outcomes included episodes of postoperative vomiting in times.
Measured: 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).
Measured: 6 months after surgery
Secondary outcomes (8)
operating and anaesthetic time
Secondary outcomes included operating and anaesthetic time in minutes.
Measured: 6 months after surgery
myotomy length
Secondary outcomes included myotomy length in centimeters
Measured: 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).
Measured: 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.)
Measured: 6 months after surgery
analgesia requirements
Secondary outcomes included analgesia requirements (yes or no).
Measured: 6 months after surgery
time to full enteral feed
Secondary outcomes included time to full enteral feed in hours.
Measured: 6 months after surgery
postoperative length of stay
Secondary outcomes included postoperative length of stay in days.
Measured: 6 months after surgery
need for re-operation
Secondary outcomes included need for re-operation (yes or no).
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Jan 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile Hypertrophic Pyloric StenosisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pinghong Zhou, Study chair, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148040
- Sponsor's protocol ID
- ZSLQL
- Status last verified
- Nov 2019
- First submitted
- 12 Oct 2019
- Last updated
- 14 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis
- ClinicalTrials.gov ID
- NCT04148040
- Acronym / sponsor ID
- ZSLQL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G-POEM for infantile hypertrophic pyloric stenosis | Experimental | Procedure: G-POEMThe 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. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Clinical diagnosis of pyloric stenosis with or without sonographic confirmation.
Key exclusion criteria (2 listed)
- Comorbid conditions that could affect postoperative recovery.
- Needed an additional procedure during the same anaesthetic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-POEMPer-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. | Procedure or surgery | G-POEM for infantile hypertrophic pyloric stenosis |
Primary outcome
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).
8 secondary outcomes
operating and anaesthetic time
Time frame: 6 months after surgery
myotomy length
Time frame: 6 months after surgery
other complications
Time frame: 6 months after surgery
postoperative pain assessment by "Pain assessment for children under four years"
Time frame: 6 months after surgery
analgesia requirements
Time frame: 6 months after surgery
time to full enteral feed
Time frame: 6 months after surgery
postoperative length of stay
Time frame: 6 months after surgery
need for re-operation
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pinghong Zhou study chair
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-POEM in people with Infantile Hypertrophic Pyloric Stenosis and Pyloromyotomy, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quanlin Li (64041990, li.quanlin@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
episodes of postoperative vomiting (time frame: 6 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.