Clinical trial NCT00903799: Medico-economic Evaluation of ENTERRA Therapy
Official title: Clinical Efficacy and Efficiency of Gastric Electrical Stimulation (Enterra®) for Refractory Nausea and/or Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroparesis
Vomiting
Nausea
Keywords: Drug-refractory gastroparesis
diabetes mellitus induced gastroparesis
Gastric electrical stimulation
Long-term multicenter study
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2009-05-18
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: clinical efficacy
timeFrame: 24 months
Secondary outcomes:
measure: medico-economic evaluation of ENTERRA therapy
timeFrame: 28 months
Other outcomes:
Locations:
city: Besancon
country: France
facility: UH Besancon
city: Bondy
country: France
facility: AP-HP Jean Verdier
city: Bordeaux
country: France
facility: UH Bordeaux
city: Clermont Ferrand
country: France
facility: UH Clermont Ferrand
city: Colombes
country: France
facility: AP-HP Louis Mourier
city: Corbeil-Essonnes
country: France
facility: Corbeil Essones Hospital
city: Grenoble
country: France
facility: UH Grenoble
city: Lille
country: France
facility: UH Lille
city: Lyon
country: France
facility: UH Lyon
city: Marseille
country: France
facility: UH Marseille
city: Montpellier
country: France
facility: UH Montpellier
city: Nancy
country: France
facility: UH Nancy
city: Nantes
country: France
facility: UH Nantes
city: Nice
country: France
facility: UH Nice
city: Nimes
country: France
facility: UH Nimes
city: Poitiers
country: France
facility: UH Poitiers
city: Rennes
country: France
facility: UH Rennes
city: Rouen
country: France
facility: UH Rouen
city: Strasbourg
country: France
facility: UH Strasbourg
city: Toulouse
country: France
facility: UH Toulouse
city: Tours
country: France
facility: UH Tours
Study officials:
affiliation: UH Rouen
name: Philippe DUCROTTE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.