Endoscopic Full Thickness Biopsy, Gastric Wall.

Overview

About this study

The proposed study will assess the efficacy and safety of the innovative endoscopic technique for the acquisition of full thickness gastric muscle wall biopsies. Having access to full thickness biopsies will allow an increased understanding of the pathophysiology of gastrointestinal diseases such as functional gastrointestinal disorders, gastroparesis, pseudoobstruction and other motility disorders. This information is essential to development of more targeted and effective therapy than currently available. Despite the high prevalence of functional gastrointestinal disorders and its significant impact on social and health care costs, the underlying cause is not well understood and there is no effective specific treatment to successfully alleviate patient symptoms.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  1. Symptomatic refractory idiopathic gastroparesis:
    • The refractory nature of symptoms (e.g. based on nutritional failure, consideration for enteral or parenteral nutrition) will be determined by the physician/gastroenterologist who is the primary care provider for the patient's gastroparesis.
    • Patients will have documentation within the last 2 years of delayed gastric emptying with >30% retained gastric contents at 4 hours based on 296 kcal solid-liquid, fat-containing standard meal gastric emptying test.
    • The patient's physician will determine if this procedure may potentially provide prognostic and therapeutic options.
  2. Age > 18 and < 70 years old
  3. Hemoglobin (Hb) > 10g, platelets >150,000 and prothrombin time- international normalized ratio (INR) <1.5
  4. Ability to give informed consent

Exclusion Criteria:

  1. Prior oropharyngeal, esophageal, gastric or small bowel surgery
  2. Esophageal stricture
  3. Prior abdominal radiation therapy
  4. Prior feeding tube placement
  5. Coagulopathy
  6. Use of Coumadin or anti-platelet drugs e.g. Plavix, steroids or immunosuppressive drugs
  7. Pregnancy

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Elizabeth Rajan, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20112079

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