Medico-economic Evaluation of ENTERRA Therapy (ENTERRA)
Clinical Efficacy and Efficiency of Gastric Electrical Stimulation (Enterra®) for Refractory Nausea and/or Vomiting
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Besancon, France, 25030
- UH Besançon
-
Bondy, France, 93143
- AP-HP Jean Verdier
-
Bordeaux, France, 33076
- UH Bordeaux
-
Clermont Ferrand, France, 63000
- UH Clermont Ferrand
-
Colombes, France, 92071
- AP-HP Louis Mourier
-
Corbeil-Essonnes, France, 91106
- Corbeil Essones Hospital
-
Grenoble, France, 38043
- UH Grenoble
-
Lille, France, 59000
- UH Lille
-
Lyon, France, 69000
- UH Lyon
-
Marseille, France, 13000
- UH Marseille
-
Montpellier, France, 34000
- Uh Montpellier
-
Nancy, France, 54000
- UH Nancy
-
Nantes, France, 44000
- Uh Nantes
-
Nice, France, 06202
- UH Nice
-
Nimes, France, 30029
- UH Nîmes
-
Poitiers, France, 86021
- UH Poitiers
-
Rennes, France, 35033
- UH Rennes
-
Rouen, France, 76031
- UH Rouen
-
Strasbourg, France, 67091
- UH Strasbourg
-
Toulouse, France, 31075
- Uh Toulouse
-
Tours, France, 37044
- UH Tours
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 1
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 |
Gastric electrical stimulation using Enterra Therapy
|
|
Other: 2
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 |
Gastric electrical stimulation using Enterra Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
clinical efficacy
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
medico-economic evaluation of ENTERRA therapy
Time Frame: 28 months
|
28 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philippe DUCROTTE, Pr, UH Rouen
Publications and helpful links
General Publications
- Gourcerol G, Coffin B, Bonaz B, Hanaire H, Bruley Des Varannes S, Zerbib F, Caiazzo R, Grimaud JC, Mion F, Hadjadj S, Valensi P, Vuitton L, Charpentier G, Ropert A, Altwegg R, Pouderoux P, Dorval E, Dapoigny M, Duboc H, Benhamou PY, Schmidt A, Donnadieu N, Ducrotte P, Guerci B; ENTERRA Research Group. Impact of Gastric Electrical Stimulation on Economic Burden of Refractory Vomiting: A French Nationwide Multicentre Study. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1857-1866.e1. doi: 10.1016/j.cgh.2020.11.011. Epub 2020 Nov 13.
- Ducrotte P, Coffin B, Bonaz B, Fontaine S, Bruley Des Varannes S, Zerbib F, Caiazzo R, Grimaud JC, Mion F, Hadjadj S, Valensi PE, Vuitton L, Charpentier G, Ropert A, Altwegg R, Pouderoux P, Dorval E, Dapoigny M, Duboc H, Benhamou PY, Schmidt A, Donnadieu N, Gourcerol G, Guerci B; ENTERRA Research Group. Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial. Gastroenterology. 2020 Feb;158(3):506-514.e2. doi: 10.1053/j.gastro.2019.10.018. Epub 2019 Oct 21.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008/046/HP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.