Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/27/2018 |
| Start Date: | January 10, 2017 |
| End Date: | December 15, 2020 |
| Contact: | Irene Sarosiek, MD |
| Email: | irene.sarosiek@ttuhsc.edu |
| Phone: | 915-215-5254 |
Combined Gastric Electrical Stimulation (GES) and Pyloroplasty for the Treatment of Gastroparesis: Can Pyloroplasty be Effective Without GES?
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.
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.
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.
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.
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
We found this trial at
1
site
415 East Yandell Drive
El Paso, Texas 79905
El Paso, Texas 79905
Principal Investigator: Irene Sarosiek, MD
Phone: 915-215-5254
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