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Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis

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ClinicalTrials.gov Identifier: NCT04148040
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Infantile Hypertrophic Pyloric Stenosis Pyloromyotomy Procedure: G-POEM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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.




Primary Outcome Measures :
  1. episodes of postoperative vomiting [ Time Frame: 6 months after surgery ]
    Primary outcomes included episodes of postoperative vomiting in times.

  2. 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 Outcome Measures :
  1. operating and anaesthetic time [ Time Frame: 6 months after surgery ]
    Secondary outcomes included operating and anaesthetic time in minutes.

  2. myotomy length [ Time Frame: 6 months after surgery ]
    Secondary outcomes included myotomy length in centimeters

  3. 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).

  4. 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.)


  5. analgesia requirements [ Time Frame: 6 months after surgery ]
    Secondary outcomes included analgesia requirements (yes or no).

  6. time to full enteral feed [ Time Frame: 6 months after surgery ]
    Secondary outcomes included time to full enteral feed in hours.

  7. postoperative length of stay [ Time Frame: 6 months after surgery ]
    Secondary outcomes included postoperative length of stay in days.

  8. need for re-operation [ Time Frame: 6 months after surgery ]
    Secondary outcomes included need for re-operation (yes or no).



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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04148040


Contacts
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Contact: Quanlin Li 64041990 li.quanlin@zs-hospital.sh.cn
Contact: Zuqiang Liu 64041990 16111210047@fudan.edu.cn

Locations
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China
Zhongshan hospital Recruiting
Shanghai, China
Contact: Quanlin Li    64041990    li.quanlin@zs-hospital.sh.cn   
Contact: Zuqiang Liu    64041990    16111210047@fudan.edu.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Chair: Pinghong Zhou Shanghai Zhongshan Hospital
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04148040    
Other Study ID Numbers: ZSLQL
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pyloric Stenosis
Gastric Outlet Obstruction
Pyloric Stenosis, Hypertrophic
Constriction, Pathologic
Hypertrophy
Pathological Conditions, Anatomical
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases