Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.

Gastroparesis Clinical Trial

— GASTROPOP  

Official title:

Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779920
• Other study ID #: I15002 (GASTROPOP)
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2020
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gastroparesis is a common chronic condition, disabling the limited therapeutic resources justifying the exploration of new therapeutic possibilities.

By 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.

Description:

Experimental study, prospective, single-center, POP feasibility pilot in the treatment of refractory gastroparesis.

Patients 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.

20 patients will be prospectively included 10 patients with diabetic gastroparesis, 10 patients with non-diabetic gastroparesis (post-surgical, post-Sjogren, idiopathic).

POP 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.

An 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with refractory gastroparesis to drug treatment (post-diabetic, post-Sjogren, postsurgical or idiopathic)

• Signed Consent

• Affiliate or beneficiary of a French social security scheme

Exclusion Criteria:

• Contraindications to gastroesophageal gastroduodenal endoscopy,

• Early Unable to follow protocol,

• Contraindications to general anesthesia,

• Can not Stop anticoagulants for the gesture,

• Can not stop antiplatelet agents for the gesture,

• Pregnant or lactating women,

• Gastric resection surgery History of pyloric

• Patients under guardianship, curatorship or safeguard justice,

• Disorders of hemostasis against-indicating the endoscopic procedure.

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Procedure:
• per oral pylorotomy
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.

Locations

Country	Name	City	State
France	CHU de LIMOGES	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

References & Publications (1)

Jacques J, Pagnon L, Hure F, Legros R, Crepin S, Fauchais AL, Palat S, Ducrotté 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of technical success for endoscopic pylorotomy on the total number of gestures.	Technical feasibility will be the feasibility of endoscopic pylorotomy gesture by the technique of the tunnel.	3 months
Secondary	Incidence of adverse events of pylorotomy	analysis of adverse events during the 3 months following the pylorotomy (including perforation per-gesture, bleeding post-gesture)	3 months
Secondary	Ratio between the diameter of the pyloric canal and the pyloric pressure	Evaluation of the pyloric compliance by the Endolumenal Functional Lumen Imaging Probe (EndoFLIP) system before the procedure and at 3 months, depending on etiology.	Baseline and 3 months
Secondary	Assessment of gastric emptying scintigraphy	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	baseline and 3 months
Secondary	Assessment of gastroparesis severity symptom using the Gastroparesis Cardinal Symptom Index (GCSI)	Evaluation of the severity of gastroparesis symptom using the GCSI questionnaire	Baseline, 1 month and 3 month
Secondary	Assessment of Quality of Life in Upper Gastrointestinal Disorders (PAGI-QOL)	Evaluation of the quality of life of patient with Upper Gastrointestinal Disorders using PAGI-QOL questionnaire	Baseline, 1 month and 3 month
Secondary	Assessment of Quality of Life in Gastrointestinal disease (GIQLI)	Evaluation of quality of life of patients with gastrointestinal Disease using GIQLI questionnaire	Baseline, 1 month and 3 month
Secondary	Assessment of functional health and well-being from the patient's point of view (SF-36)	Evaluation of of functional health and well-being from the patient's point of view using SF-36 questionnaire	Baseline, 1 month and 3 month
Secondary	Consumption of gastric prokinetic drugs	Data collecting about domperidone, metoclopramide and erythromycin consumption.	3 months