Medico-economic Evaluation of ENTERRA Therapy (ENTERRA)

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Gastroparesis; Vomiting; Nausea	Device: Implantation of ENTERRA therapy	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	220 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Clinical Efficacy and Efficiency of Gastric Electrical Stimulation (Enterra®) for Refractory Nausea and/or Vomiting
Study Start Date :	June 2009
Actual Primary Completion Date :	October 2014
Actual Study Completion Date :	November 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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	Device: Implantation of ENTERRA therapy; Gastric electrical stimulation using Enterra Therapy
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	Device: Implantation of ENTERRA therapy; Gastric electrical stimulation using Enterra Therapy

Outcome Measures

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Primary Outcome Measures :

1. clinical efficacy [ Time Frame: 24 months ]

Secondary Outcome Measures :

1. medico-economic evaluation of ENTERRA therapy [ Time Frame: 28 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Nausea and/or vomiting refractory to prokinetics and antiemetics fulfilling the following criteria

1. Due to diabetes mellitus type 1, secondary to oesogastric surgery (vagotomy, partial gastric resection) or idiopathic
2. Non related to other cause
3. Chronic (duration > 12 months)
4. Occurring at least weekly
5. Refractory to anti-emetics (chlorpromazine, ondansétron, granisétron) and/or prokinetics (domperidone, metoclopramide, erythromycin),
6. Leading to weight loss or significant reduction of food intake
7. occurring in patients without any contra-indication for the surgical implantation of the device, in particular severe cardiac or respiratory failure or haemostasis disorders,
8. in patients older than 18 years
9. with a negative pregnancy test at entry into the trial in women
10. Patients who signed the study consentment
11. Affiliation to the the welfare system

Exclusion Criteria:

1. Patients older than 70,
2. Patients in whom nausea and/or vomiting are related to another aetiology than that previously described.
3. Patients with an absolute contraindication for general anaethesia and surgery
4. Patients with a contra-indication for implantation of the device
5. Patients with a severe psychiatric disorder
6. Patients under guardianship or curatorship
7. Patients with a major obesity or as severe eating disorder.
8. Patients unable to understand French.
9. Pregnant women or nursing mothers
10. Lack of effective contraception
11. Patients having undergone a pancreatic graft within the previous 6 months and being in a unstable clinical conditions at enrollment
12. Patients with an underlying disease leading to a follow-up by MRI

Contacts and Locations

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Locations

France
UH Besancon
Besancon, France, 25030
AP-HP Jean Verdier
Bondy, France, 93143
UH Bordeaux
Bordeaux, France, 33076
UH Clermont Ferrand
Clermont Ferrand, France, 63000
AP-HP Louis Mourier
Colombes, France, 92071
Corbeil Essones Hospital
Corbeil-Essonnes, France, 91106
UH Grenoble
Grenoble, France, 38043
UH Lille
Lille, France, 59000
UH Lyon
Lyon, France, 69000
UH Marseille
Marseille, France, 13000
UH Montpellier
Montpellier, France, 34000
UH Nancy
Nancy, France, 54000
UH Nantes
Nantes, France, 44000
UH Nice
Nice, France, 06202
UH Nimes
Nimes, France, 30029
UH Poitiers
Poitiers, France, 86021
UH Rennes
Rennes, France, 35033
UH Rouen
Rouen, France, 76031
UH Strasbourg
Strasbourg, France, 67091
UH Toulouse
Toulouse, France, 31075
UH Tours
Tours, France, 37044

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:	Philippe DUCROTTE, Pr	UH Rouen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00903799 History of Changes
Other Study ID Numbers:	2008/046/HP
First Posted:	May 18, 2009
Last Update Posted:	May 26, 2016
Last Verified:	May 2016

Keywords provided by University Hospital, Rouen:

Drug-refractory gastroparesis; diabetes mellitus induced gastroparesis; Gastric electrical stimulation; Long-term multicenter study

Additional relevant MeSH terms:

Nausea; Vomiting; Gastroparesis; Signs and Symptoms, Digestive; Signs and Symptoms	Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations