Symptoms of gastroparesis can be so severe in some people with the condition that they cannot adequately manage with dietary changes and medications. Disabling symptoms can significantly diminish quality of life in people. Persistent symptoms resistant to treatment (refractory) sometimes result in life-threatening dehydration, loss of essential minerals (electrolyte imbalances), and malnutrition requiring hospitalizations. Special treatment measures to help manage may then be considered. These may include:
- enteral nutrition,
- parenteral nutrition,
- gastric electrical stimulation, or
- other surgical procedures.
Enteral nutrition involves the delivery of liquid food into the digestive tract through a feeding tube. It is used when oral eating does not supply adequate nutrition. Delivery into the small intestine is called a jejunostomy.
Jejunostomy (J-tube) is a surgical procedure that places a feeding tube through the abdominal wall directly into the small intestine, bypassing the stomach. In this procedure, the feeding tube delivers nutrients in a specially formulated liquid food directly into the jejunum, the part of the small intestine where most nutrients are absorbed into the body. (A temporary, nasojejunal, feeding tube should be tried first to test individual toleration of this feeding method.)
Parenteral nutrition bypasses the digestive system. It involves the delivery of fluids, electrolytes, and liquid nutrients into the bloodstream through a tube surgically placed in a vein (intravenous or IV). Parenteral nutrition is a complex therapy, used when no other treatments are working. Long-term use increases risks for infections and other complications. It may be used as a temporary treatment for gastroparesis.
Gastric electric stimulation (GES) uses a battery-operated surgically implanted device (Enterra) on the stomach to try to help reduce symptoms of nausea and vomiting in gastroparesis when other methods have failed. Low voltage pulses are too weak to excite stomach smooth muscles, but are able to excite nerves. Therapy with Enterra is FDA approved through a Humanitarian Use Device exemption. The device can be implanted laparoscopically, which helps minimize chances for complications related to surgery. Once implanted, the settings on the battery-operated device can be adjusted to determine the settings that best control symptoms.
First FDA approved in 2000, the FDA approved a second-generation device (Enterra II) in 2015. The newer device provides physicians with greater system flexibility and ease of use.
Enterra therapy is not a cure and other treatment approaches need to be continued. The device can be removed if the therapy does not work.
Other surgical procedures may sometimes be tried in patients where all other treatments fail. Gastrostomy (a tube into the stomach) venting prevents excess air and fluid from building up in the stomach and may help with severe nausea and vomiting. Pyloroplasty (surgery to widen the lower part of the stomach) or gastrojejunostomy (surgical procedure that connects the stomach to the jejunum part of the small intestine) are attempts to help the stomach empty. Gastrectomy is the surgical removal of part or the whole stomach. The effectiveness of these procedures in the treatment of gastroparesis is still under investigation. These procedures should only be considered after careful discussion and review of all alternatives in selected patients with special circumstances and needs.
Humanitarian Use Device Exemption
The Enterra Therapy system for gastric electrical stimulation to treat chronic nausea and vomiting in gastroparesis is approved by the U.S. Food and Drug Administration (FDA) as a Humanitarian Use Device. What does this mean? The FDA has a specialized process, which was established by Congress for developing treatments for rare disease populations, the Humanitarian Use Device (HUD) process. Devices reviewed and approved through this process receive a Humanitarian Device Exemption (HDE).
Despite the fact that these devices are reviewed and approved by FDA, since they were not approved through the standard process many insurance companies will deem them “investigational” and refuse to cover the procedures. In these cases, the cost of the treatment alone can be enough to significantly restrict patient access. While Enterra is not for everyone, some individuals benefit greatly and can be restored to a productive lifestyle. The fact that individuals seeking Enterra or other beneficial rare disease treatments may be denied access to the treatment by a third-party payer is an issue that needs to be addressed.
IFFGD advocates have taken action on this issue by urging Members of Congress to reach out to FDA and the Center for Medicare and Medicaid Services to raise awareness of this issue and urge the agencies to show strong leadership in addressing it. Guidance needs to be issued to the insurance industry which states, in no uncertain terms, that an HDE constitutes an FDA-approval and these treatment options should be covered whenever it is feasible and appropriate.
Adapted from IFFGD Publication: Gastroparesis (Delayed Gastric Emptying) by J. Patrick Waring, MD, Digestive Healthcare of Georgia, Atlanta, GA; and William F. Norton, Communications Director, International Foundation for Functional Gastrointestinal Disorders, Milwaukee, WI.