Medico-economic Evaluation of ENTERRA Therapy

Study Overview
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Brief Summary
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The aim of this clinical trial is to assess the symptomatic efficacy and the impact on the utilization of healthcare resources of a treatment by gastric electrical stimulation (ENTERRA ®) in patients with refractory nausea and/or vomiting leading to a nutritional impairment. Eligible patients will be those with refractory symptoms either idiopathic, postsurgical or due to diabetes mellitus. The duration of the study will be 28 months for each patient. After a run-in period of 4 months during which a prospective assessment of healthcare resources utilization and of the severity of the symptoms will be obtained, patients will be implanted. The follow-up period after implantation of the device will last 24 months in every patients and will be divided in two parts: a) After the first postoperative month during which the device will remained on the OFF position, the first phase of the study will be a randomized double-blind cross-over study with 2 periods of 4 months during which the device will be activated or not. After the 9th month of follow up, the trial will be an open trial and the device will be activated in all patients. During the whole trial, patients will record all types of healthcare resources utilizations (hospitalizations, drug treatments, endoscopic procedures…) while the symptomatic efficacy of the treatment will be assessed by standard questionnaires at the following visits scheduled at 1, 5, 9, 12, 18, 24 months. The glycemic control will be determined at each visit in diabetic patients. A delayed gastric emptying will not be a selection criteria but we have planned to analyze the clinical results of the treatment in taking into account a delayed or normal gastric emptying during the pre-implantation period. Moreover, gastric emptying studies have been scheduled at 5, 9, 12 and 24 months to test the impact of gastric electrical stimulation on gastric emptying.

Official Title
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Clinical Efficacy and Efficiency of Gastric Electrical Stimulation (Enterra®) for Refractory Nausea and/or Vomiting

Conditions
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Gastroparesis, Vomiting, Nausea

Intervention / Treatment
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* Device: Implantation of ENTERRA therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nausea and/or vomiting refractory to prokinetics and antiemetics fulfilling the following criteria Due to diabetes mellitus type 1, secondary to oesogastric surgery (vagotomy, partial gastric resection) or idiopathic Non related to other cause Chronic (duration > 12 months) Occurring at least weekly Refractory to anti-emetics (chlorpromazine, ondansétron, granisétron) and/or prokinetics (domperidone, metoclopramide, erythromycin), Leading to weight loss or significant reduction of food intake occurring in patients without any contra-indication for the surgical implantation of the device, in particular severe cardiac or respiratory failure or haemostasis disorders, in patients older than 18 years with a negative pregnancy test at entry into the trial in women Patients who signed the study consentment Affiliation to the the welfare system Exclusion Criteria: Patients older than 70, Patients in whom nausea and/or vomiting are related to another aetiology than that previously described. Patients with an absolute contraindication for general anaethesia and surgery Patients with a contra-indication for implantation of the device Patients with a severe psychiatric disorder Patients under guardianship or curatorship Patients with a major obesity or as severe eating disorder. Patients unable to understand French. Pregnant women or nursing mothers Lack of effective contraception Patients having undergone a pancreatic graft within the previous 6 months and being in a unstable clinical conditions at enrollment Patients with an underlying disease leading to a follow-up by MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Gastric electrical stimulation using Enterra Therapy. Device activated during 4 months then device in 'OFF' position the 4 following months. After the cross-over period, device activated until the end of the trial | Device: Implantation of ENTERRA therapy<br>* Gastric electrical stimulation using Enterra Therapy<br>|
| Other: 2<br>Gastric electrical stimulation using Enterra Therapy. Device in 'OFF' position during 4 months then device activated the 4 following months. After the cross-over period, device activated until the end of the trial | Device: Implantation of ENTERRA therapy<br>* Gastric electrical stimulation using Enterra Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical efficacy |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| medico-economic evaluation of ENTERRA therapy |  | 28 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-refractory gastroparesis, diabetes mellitus induced gastroparesis, Gastric electrical stimulation, Long-term multicenter study