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

Gastroparesis Clinical Trial

— GES+PP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03123809
• Other study ID #: E16156
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: September 15, 2024

Study information

• Verified date: April 2023
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: Irene Sarosiek, MD
• Phone: 915-215-5254
• Email: irene.sarosiek[@]ttuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of total gastroparesis symptom scores (TSS)	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.	up to 7 months
Secondary	Total Symptom Score (TSS) with severity and frequency of gastroparesis symptoms in each etiological subgroup of patients	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)	Up to 7 months
Secondary	Associations between changes in gastric emptying and TSS	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.	Up to 7 months
Secondary	Percentage of changes of gastric emptying retention of the radiolabeled meal (%) at 2-4 hrs	Scintigraphy Gastric Emptying Test (GET) will be recorded at baseline and after 3 months of randomized phase (GES ON or OFF)	up to 7 months