Medico-economic Evaluation of ENTERRA Therapy

NCT ID: NCT00903799

Last Updated: 2016-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2015-11-30

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.

Conditions

Gastroparesis; Vomiting; Nausea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: OTHER

Implantation of ENTERRA therapy

Intervention Type: DEVICE

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

Group Type: OTHER

Implantation of ENTERRA therapy

Intervention Type: DEVICE

Gastric electrical stimulation using Enterra Therapy

Interventions

Implantation of ENTERRA therapy

Gastric electrical stimulation using Enterra Therapy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe DUCROTTE, Pr

Role: PRINCIPAL_INVESTIGATOR

UH Rouen

Locations

UH Besancon

Besançon, , France

AP-HP Jean Verdier

Bondy, , France

UH Bordeaux

Bordeaux, , France

UH Clermont Ferrand

Clermont-Ferrand, , France

AP-HP Louis Mourier

Colombes, , France

Corbeil Essones Hospital

Corbeil-Essonnes, , France

UH Grenoble

Grenoble, , France

UH Lille

Lille, , France

UH Lyon

Lyon, , France

UH Marseille

Marseille, , France

UH Montpellier

Montpellier, , France

UH Nancy

Nancy, , France

UH Nantes

Nantes, , France

UH Nice

Nice, , France

UH Nimes

Nîmes, , France

UH Poitiers

Poitiers, , France

UH Rennes

Rennes, , France

UH Rouen

Rouen, , France

UH Strasbourg

Strasbourg, , France

UH Toulouse

Toulouse, , France

UH Tours

Tours, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 33189854 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31647902 (View on PubMed)

Other Identifiers

2008/046/HP

Identifier Type: -

Identifier Source: org_study_id