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Medico-economic Evaluation of ENTERRA Therapy (ENTERRA)

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ClinicalTrials.gov Identifier: NCT00903799
Recruitment Status : Completed
First Posted : May 18, 2009
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903799


Locations
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Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Philippe DUCROTTE, Pr UH Rouen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00903799    
Other Study ID Numbers: 2008/046/HP
First Posted: May 18, 2009    Key Record Dates
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:
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Gastroparesis
Nausea
Vomiting
Signs and Symptoms, Digestive
Stomach Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations