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. In more severe cases of gastroparesis, a tube may be inserted in the stomach and small intestine with endoscopy, radiology team or surgeons. This tube is referred to as a Gastrostomy-Jejunostomy (G/J tube). By inserting the tube into the small intestines, it can help bypass the stomach in patients with delayed stomach emptying such as patients with gastroparesis. A 6 to 12-inch tube comes out of the stomach or small intestines to allow foods via nutritional formula as well as your medications to be fed through the tube. This is managed with the support of a healthcare provider and dietitian.
In severe gastroparesis cases, when feeding by mouth and tube feeding is not possible, an intravenous (IV) catheter may be placed to provide nutrition while avoiding the GI tract. This is usually placed in the arm and is called a PICC line. An IV catheter is a small flexible tube that goes into a vein. Formula placed into the catheter is specially made to provide nutrients that the body does not need to digest. This allows nutrients to go directly into the blood and be absorbed by the body.
G-Poem is a gastric perioral endoscopic myotomy and is a surgery where the pyloric muscle is cut by a surgeon to enable opening of the pyloric muscle. This may help improve gastric emptying in a minority of patients. A surgeon or advanced endoscopist performs this procedure.
Gastric electric stimulation (GES)
A small device that is implanted surgically under the skin to the lower region of the abdomen for a specific population of patients with GP that may be refractory, or non-responsive, to other GP therapies. GES has been shown to improve vomiting frequency and nausea; however, it does not improve gastric emptying.
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
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)
- 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.
Updated October 2021
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.
Also Adapted from IFFGD Publication Gastroparesis Overview by Baharak Moshiree MD MSc, Mackenzie Jarvis PA-C, DMs, Atrium Health, Wake Forest, Digestive Health-Morehead Medical Plaza; Marissa Lombardi, International Foundation for Gastrointestinal Disorders, Mt. Pleasant, SC