Endoscopic Full Thickness Biopsy, Gastric Wall.

NCT01650714 | Completed DMC

• 1 other identifier: 12-000714
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Number of patients with successful endoscopic full thickness gastric resection

  Success of the endoscopic resection will be defined by efficacy and safety: 1) Efficacy is defined as obtaining a full thickness resection and 2) Safety is defined as the absence of serious adverse events.

  one week after surgery

Study Arms (1)

Full thickness gastric biopsy

EXPERIMENTAL

Full thickness gastric biopsy

Other: Full thickness gastric biopsy; Procedure: Full thickness gastric biopsy

Interventions

Full thickness gastric biopsy OTHER

Full thickness gastric biopsy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age \> 18 and \< 70 years old
• Hemoglobin (Hb) \> 10g, platelets \>150,000 and prothrombin time- international normalized ratio (INR) \<1.5
• Ability to give informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth Rajan, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 26, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

US (1)