Medico-economic Evaluation of ENTERRA Therapy
ENTERRA
Clinical Efficacy and Efficiency of Gastric Electrical Stimulation (Enterra®) for Refractory Nausea and/or Vomiting
1 other identifier
interventional
220
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 18, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedMay 26, 2016
May 1, 2016
5.3 years
May 14, 2009
May 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical efficacy
24 months
Secondary Outcomes (1)
medico-economic evaluation of ENTERRA therapy
28 months
Study Arms (2)
1
OTHERGastric 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
2
OTHERGastric 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
UH Besancon
Besançon, 25030, France
AP-HP Jean Verdier
Bondy, 93143, France
UH Bordeaux
Bordeaux, 33076, France
UH Clermont Ferrand
Clermont-Ferrand, 63000, France
AP-HP Louis Mourier
Colombes, 92071, France
Corbeil Essones Hospital
Corbeil-Essonnes, 91106, France
UH Grenoble
Grenoble, 38043, France
UH Lille
Lille, 59000, France
UH Lyon
Lyon, 69000, France
UH Marseille
Marseille, 13000, France
UH Montpellier
Montpellier, 34000, France
UH Nancy
Nancy, 54000, France
UH Nantes
Nantes, 44000, France
UH Nice
Nice, 06202, France
UH Nimes
Nîmes, 30029, France
UH Poitiers
Poitiers, 86021, France
UH Rennes
Rennes, 35033, France
UH Rouen
Rouen, 76031, France
UH Strasbourg
Strasbourg, 67091, France
UH Toulouse
Toulouse, 31075, France
UH Tours
Tours, 37044, France
Related Publications (2)
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.
PMID: 33189854DERIVEDDucrotte 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.
PMID: 31647902DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe DUCROTTE, Pr
UH Rouen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 18, 2009
Study Start
June 1, 2009
Primary Completion
October 1, 2014
Study Completion
November 1, 2015
Last Updated
May 26, 2016
Record last verified: 2016-05