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Completed

NCT Number: NCT02779920

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

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.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de LIMOGES

Limoges, 87042, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

per oral pylorotomy

Procedure

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.

Primary outcomes

  1. Number of technical success for endoscopic pylorotomy on the total number of gestures.

    Time frame: 3 months

    Technical feasibility will be the feasibility of endoscopic pylorotomy gesture by the technique of the tunnel.

Secondary outcomes

  1. Incidence of adverse events of pylorotomy

    Time frame: 3 months

    analysis of adverse events during the 3 months following the pylorotomy (including perforation per-gesture, bleeding post-gesture)

  2. Ratio between the diameter of the pyloric canal and the pyloric pressure

    Time frame: Baseline and 3 months

    Evaluation of the pyloric compliance by the Endolumenal Functional Lumen Imaging Probe (EndoFLIP) system before the procedure and at 3 months, depending on etiology.

  3. Assessment of gastric emptying scintigraphy

    Time frame: baseline and 3 months

    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

  4. Assessment of gastroparesis severity symptom using the Gastroparesis Cardinal Symptom Index (GCSI)

    Time frame: Baseline, 1 month and 3 month

    Evaluation of the severity of gastroparesis symptom using the GCSI questionnaire

  5. Assessment of Quality of Life in Upper Gastrointestinal Disorders (PAGI-QOL)

    Time frame: Baseline, 1 month and 3 month

    Evaluation of the quality of life of patient with Upper Gastrointestinal Disorders using PAGI-QOL questionnaire

  6. Assessment of Quality of Life in Gastrointestinal disease (GIQLI)

    Time frame: Baseline, 1 month and 3 month

    Evaluation of quality of life of patients with gastrointestinal Disease using GIQLI questionnaire

  7. Assessment of functional health and well-being from the patient's point of view (SF-36)

    Time frame: Baseline, 1 month and 3 month

    Evaluation of of functional health and well-being from the patient's point of view using SF-36 questionnaire

  8. Consumption of gastric prokinetic drugs

    Time frame: 3 months

    Data collecting about domperidone, metoclopramide and erythromycin consumption.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: GASTROPOP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 23, 2016
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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