GES+PP: Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis

Sponsor

Texas Tech University Health Sciences Center, El Paso (Other)

Overall Status

Recruiting

CT.gov ID

NCT03123809

Collaborator

(none)

Enrollment

Location

Arms

76.1

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Gastroparesis (GP) is describing a condition when stomach does not empty as fast as it should. This fact creates the situation, when food stays in the stomach for a long time and it causes symptoms of nausea, vomiting, loss of appetite, bloating, inability to finish normal size meal and abdominal pain. There are not many drugs available to treat this condition and majority of gastroparetic patients are not responding well to them after they are on it for some time. Many investigators are able to implant Gastric Stimulator System (GES) under FDA approved status of Humanitarian Device Exemption (HDE) definition. In the last few years it became possible to add another surgical procedure, which is called pyloroplasty (making bigger opening on the end of stomach), may help even more as it is also increasing the rate of the emptying of the stomach. Therefore this study is proposing to evaluate if GES in combination with pyloroplasty is much better than pyloroplasty alone. For this reason, two of these procedures will be introduced surgically at the same time, but GES devices will not be turn ON in half of these participants for 3 months. After that time all subjects will have their devices turned ON. All subjects will be asked to evaluate their symptoms of gastroparesis and their quality of life during clinical visits, and investigators will conduct pathological analyses of tissue obtained during surgery.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis	Device: Gastric Electrical Stimulation (GES) System	N/A

Detailed Description

GES system (Enterra Therapy) involves surgical implantation of a pulse generator in the abdominal wall and 2 electrodes into the muscularis propria of the stomach. Well established procedure, called pyloroplasty, will be performed during the implantation of GES system, therefore all participants will have both surgeries done at the same time. Half of them will be randomized to keep GES ON after surgery, and other half will have GES turned OFF for 3 months.

Both groups will be followed for additional 3 more months. Study related questionnaires and diagnostic/ clinical tests will be obtained at all points of interest of this study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Based on confidential code set up for this study, there will be a randomized assigment for patients to have their GES devices turn ON or OFF. Half of these patients will be in each arm.Based on confidential code set up for this study, there will be a randomized assigment for patients to have their GES devices turn ON or OFF. Half of these patients will be in each arm.

Masking:

Double (Participant, Investigator)

Masking Description:

Patient and clinical investigators are going to be blinded in regards to the status of GES (if it is ON or OFF) for 3 months after surgery. One non-clinical investigator is assigned to serve as un-blind person , who is going to generate a master list of participants by dividing them into two groups based on their etiologies (diabetic or idiopathic). All effort would be to include similar numbers of idiopathic and diabetic patients in each intervention group based on a block randomization method, allowing for GES to be turned ON at the surgery, or it will stay OFF for the 3 month during the blind portion of the study.

Primary Purpose:

Treatment

Official Title:

Combined Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis: Can Pyloroplasty be Effective Without GES?

Actual Study Start Date :

Jan 10, 2017

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

May 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Gastric Electrical Stimulation (GES) ON Gastric Electrical Stimulation (GES) system involves surgical implantation of a pulse generator in the abdominal wall and 2 electrodes into the muscularis propria of the stomach. After surgery this group of GP patients will have their GES programed and system will be turned ON for 3 months during a double-blind phase of the study. This step will be followed with additional 3 months of active stimulation (GES System will be turned ON) as it is described in the protocol.Therefore all subjects in this arm will receive overall 6 months of intervention, which will be provided by the active stimulation of GES System (GES turned ON for 6 months).	Device: Gastric Electrical Stimulation (GES) System Implantable GES System will be turned ON as an active intervention providing electrical stimulation to the muscle of stomach for 6 months in patients from the first arm, versus 3 months only of active stimulation in patients who are randomized to be in the second arm of the study. GES works by utilizing following parameters: Current 5 mA; Pulse Width 330µsec; Rate 14 Hz; Time ON 0.1 sec; Time OFF 5.0 sec. Other Names: Enterra II Therapy System INS Model 37800;
Placebo Comparator: Gastric Electrical Stimulation (GES) OFF Gastric Electrical Stimulation (GES) system involves surgical implantation of a pulse generator in the abdominal wall and 2 electrodes into the muscularis propria of the stomach. After surgery this group of GP patients will have their GES programed and system will be turned OFF for 3 months.This step will be followed with additional 3 months of active stimulation (GES System will be turned ON) as it is described in the protocol. Therefore all subjects in this arm will receive first 3 months of non GES intervention (GES System OFF), and 3 following months of active intervention which will be provided by the stimulation of GES System (GES turned ON for 3 months).	Device: Gastric Electrical Stimulation (GES) System Implantable GES System will be turned ON as an active intervention providing electrical stimulation to the muscle of stomach for 6 months in patients from the first arm, versus 3 months only of active stimulation in patients who are randomized to be in the second arm of the study. GES works by utilizing following parameters: Current 5 mA; Pulse Width 330µsec; Rate 14 Hz; Time ON 0.1 sec; Time OFF 5.0 sec. Other Names: Enterra II Therapy System INS Model 37800;

Arm

Intervention/Treatment

Active Comparator: Gastric Electrical Stimulation (GES) ON

Gastric Electrical Stimulation (GES) system involves surgical implantation of a pulse generator in the abdominal wall and 2 electrodes into the muscularis propria of the stomach. After surgery this group of GP patients will have their GES programed and system will be turned ON for 3 months during a double-blind phase of the study. This step will be followed with additional 3 months of active stimulation (GES System will be turned ON) as it is described in the protocol.Therefore all subjects in this arm will receive overall 6 months of intervention, which will be provided by the active stimulation of GES System (GES turned ON for 6 months).

Device: Gastric Electrical Stimulation (GES) System

Implantable GES System will be turned ON as an active intervention providing electrical stimulation to the muscle of stomach for 6 months in patients from the first arm, versus 3 months only of active stimulation in patients who are randomized to be in the second arm of the study. GES works by utilizing following parameters: Current 5 mA; Pulse Width 330µsec; Rate 14 Hz; Time ON 0.1 sec; Time OFF 5.0 sec.

Other Names:

Enterra II Therapy System INS Model 37800;

Placebo Comparator: Gastric Electrical Stimulation (GES) OFF

Gastric Electrical Stimulation (GES) system involves surgical implantation of a pulse generator in the abdominal wall and 2 electrodes into the muscularis propria of the stomach. After surgery this group of GP patients will have their GES programed and system will be turned OFF for 3 months.This step will be followed with additional 3 months of active stimulation (GES System will be turned ON) as it is described in the protocol. Therefore all subjects in this arm will receive first 3 months of non GES intervention (GES System OFF), and 3 following months of active intervention which will be provided by the stimulation of GES System (GES turned ON for 3 months).

Device: Gastric Electrical Stimulation (GES) System

Other Names:

Enterra II Therapy System INS Model 37800;

Outcome Measures

Primary Outcome Measures

Changes of total gastroparesis symptom scores (TSS) [up to 7 months]
Severity and frequency of gastroparesis symptoms will be assess at baseline /surgery, after 3 months of randomized phase (GES ON or OFF), and at the end of 3 months of clinical follow up visit.

Secondary Outcome Measures

Total Symptom Score (TSS) with severity and frequency of gastroparesis symptoms in each etiological subgroup of patients [Up to 7 months]
TSS in diabetic and idiopathic sub-group of gastroparetic patients will be compared and analyzed (if adequate number of patients will be in each subgroup)
Associations between changes in gastric emptying and TSS [Up to 7 months]
Statistical analyses of any possible correlation between retention of GET study meal and gastroparesis symptoms will be asses at the end of randomized phase of the study.
Percentage of changes of gastric emptying retention of the radiolabeled meal (%) at 2-4 hrs [up to 7 months]
Scintigraphy Gastric Emptying Test (GET) will be recorded at baseline and after 3 months of randomized phase (GES ON or OFF)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Documented diagnosis of GP for > 1 year and refractoriness to anti-emetics and prokinetics; more than 7 emetic episodes per week;
Delayed GE (gastric retention greater than 60% at 2 h and/or greater than 10% at 4 h) based on a 4-h standardized radionuclide solid meal test

Exclusion Criteria:

Organic or pseudo-obstruction, primary eating or swallowing disorders, positive pregnancy test result, psychogenic vomiting, peritoneal dialysis, drug dependent, morbid obesity, active malignancy