Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT02779920
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2016-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2016-02-23', 'studyFirstSubmitQcDate': '2016-05-18', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of technical success for endoscopic pylorotomy on the total number of gestures.', 'timeFrame': '3 months', 'description': 'Technical feasibility will be the feasibility of endoscopic pylorotomy gesture by the technique of the tunnel.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events of pylorotomy', 'timeFrame': '3 months', 'description': 'analysis of adverse events during the 3 months following the pylorotomy (including perforation per-gesture, bleeding post-gesture)'}, {'measure': 'Ratio between the diameter of the pyloric canal and the pyloric pressure', 'timeFrame': 'Baseline and 3 months', 'description': 'Evaluation of the pyloric compliance by the Endolumenal Functional Lumen Imaging Probe (EndoFLIP) system before the procedure and at 3 months, depending on etiology.'}, {'measure': 'Assessment of gastric emptying scintigraphy', 'timeFrame': 'baseline and 3 months', 'description': 'Assessment of gastric emptying scintigraphy before the procedure and at 3 months by measuring the half gastric emptying time and percentage retention to 4 hours'}, {'measure': 'Assessment of gastroparesis severity symptom using the Gastroparesis Cardinal Symptom Index (GCSI)', 'timeFrame': 'Baseline, 1 month and 3 month', 'description': 'Evaluation of the severity of gastroparesis symptom using the GCSI questionnaire'}, {'measure': 'Assessment of Quality of Life in Upper Gastrointestinal Disorders (PAGI-QOL)', 'timeFrame': 'Baseline, 1 month and 3 month', 'description': 'Evaluation of the quality of life of patient with Upper Gastrointestinal Disorders using PAGI-QOL questionnaire'}, {'measure': 'Assessment of Quality of Life in Gastrointestinal disease (GIQLI)', 'timeFrame': 'Baseline, 1 month and 3 month', 'description': 'Evaluation of quality of life of patients with gastrointestinal Disease using GIQLI questionnaire'}, {'measure': "Assessment of functional health and well-being from the patient's point of view (SF-36)", 'timeFrame': 'Baseline, 1 month and 3 month', 'description': "Evaluation of of functional health and well-being from the patient's point of view using SF-36 questionnaire"}, {'measure': 'Consumption of gastric prokinetic drugs', 'timeFrame': '3 months', 'description': 'Data collecting about domperidone, metoclopramide and erythromycin consumption.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['refractory gastroparesis', 'per oral pyloromyotomy'], 'conditions': ['Gastroparesis']}, 'referencesModule': {'references': [{'pmid': '29895073', 'type': 'RESULT', 'citation': 'Jacques J, Pagnon L, Hure F, Legros R, Crepin S, Fauchais AL, Palat S, Ducrotte P, Marin B, Fontaine S, Boubaddi NE, Clement MP, Sautereau D, Loustaud-Ratti V, Gourcerol G, Monteil J. Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function. Endoscopy. 2019 Jan;51(1):40-49. doi: 10.1055/a-0628-6639. Epub 2018 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'Gastroparesis is a common chronic condition, disabling the limited therapeutic resources justifying the exploration of new therapeutic possibilities.\n\nBy analogy to the technique of Per Oral Endoscopic Myotomy (POEM), we believe that myotomy pyloric muscle (POP = Per Oral Pyloromyotomy) endoscopically could become a treatment of choice in the refractory gastroparesis with drug treatments by attacking the pyloric obstacle often spastic that counteracts an effective gastric emptying.', 'detailedDescription': 'Experimental study, prospective, single-center, POP feasibility pilot in the treatment of refractory gastroparesis.\n\nPatients with gastroparesis (significant prolongation of gastric emptying) unimproved by prokinetic treatment and meet all the eligibility criteria will be included after a period of reflection of two weeks minimum.\n\n20 patients will be prospectively included 10 patients with diabetic gastroparesis, 10 patients with non-diabetic gastroparesis (post-surgical, post-Sjogren, idiopathic).\n\nPOP will be performed under general anesthesia in intubated-ventilated patients using a carbon dioxide (CO2) inflator. The published standard technique and learned by our team on the pig model will be conducted: submucosal tunnel at the anterior surface of the gastric antrum starting 3-5 cm proximal to the pylorus front section to the fiber by fiber to the muscular pyloric, then closing the inlet tunnel by hemostatic clips.\n\nAn evaluation of symptoms by the Gastroparesis Cardinal Symptom Index (ISCC) of the quality of life of the patient Assessment of upper gastrointestinal disorders-Quality Of Life (PAGI-QoL), SF-36 and gastrointestinal Quality of Life Index (GIQLI ) and gastric emptying by a scintigraphic gastric emptying will be carried out at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with refractory gastroparesis to drug treatment (post-diabetic, post-Sjogren, postsurgical or idiopathic)\n* Signed Consent\n* Affiliate or beneficiary of a French social security scheme\n\nExclusion Criteria:\n\n* Contraindications to gastroesophageal gastroduodenal endoscopy,\n* Early Unable to follow protocol,\n* Contraindications to general anesthesia,\n* Can not Stop anticoagulants for the gesture,\n* Can not stop antiplatelet agents for the gesture,\n* Pregnant or lactating women,\n* Gastric resection surgery History of pyloric\n* Patients under guardianship, curatorship or safeguard justice,\n* Disorders of hemostasis against-indicating the endoscopic procedure.'}, 'identificationModule': {'nctId': 'NCT02779920', 'acronym': 'GASTROPOP', 'briefTitle': 'Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.', 'orgStudyIdInfo': {'id': 'I15002 (GASTROPOP)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Per oral pylorotomy', 'description': 'Patients with gastroparesis (significant prolongation of gastric emptying) not improved prokinetic and antiemetic treatments undergoing per oral pylorotomy', 'interventionNames': ['Procedure: per oral pylorotomy']}], 'interventions': [{'name': 'per oral pylorotomy', 'type': 'PROCEDURE', 'description': 'The procedure is endoscopic pylorotomy. The standard procedure consists in the realization of a longitudinal incision of 2 cm at the anterior surface of the gastric antrum at 5 cm from the pylorus after a submucosal injection of a solution containing 85% saline 10% glycerol and 5% fructose. This longitudinal incision serve as an input for producing a submucosal tunnel dissected fibers gastric submucosa step. The internal circular of the pyloric muscle is then severed fiber after fiber over its entire length and its entire thickness. Once the pyloric section completed, the tunnel inlet will be closed by means of hemostatic clips.', 'armGroupLabels': ['Per oral pylorotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU de LIMOGES', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}], 'overallOfficials': [{'name': 'Jérémie Jacques, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Limoges'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}