search
Back to results

Endoscopic Full Thickness Biopsy, Gastric Wall.

Primary Purpose

Gastroparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full thickness gastric biopsy
Full thickness gastric biopsy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroparesis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Symptomatic refractory idiopathic gastroparesis:

    1. 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.
    2. 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.
    3. 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 -

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Full thickness gastric biopsy

Arm Description

Full thickness gastric biopsy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2012
Last Updated
May 13, 2015
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT01650714
Brief Title
Endoscopic Full Thickness Biopsy, Gastric Wall.
Official Title
Endoscopic Full Thickness Biopsy of the Gastric Wall in Patients With Refractory Idiopathic Gastroparesis: Pilot Study to Detect Neuromuscular and Immune Pathologic Changes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Our group has studied a new endoscopic method using a submucosal endoscopy with mucosal flap (SEMF) technique to acquire full thickness gastric tissues successfully and safely in preclinical studies. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full thickness gastric biopsy
Arm Type
Experimental
Arm Description
Full thickness gastric biopsy
Intervention Type
Other
Intervention Name(s)
Full thickness gastric biopsy
Intervention Type
Procedure
Intervention Name(s)
Full thickness gastric biopsy
Primary Outcome Measure Information:
Title
Number of patients with successful endoscopic full thickness gastric resection
Description
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.
Time Frame
one week after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Rajan, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Endoscopic Full Thickness Biopsy, Gastric Wall.

We'll reach out to this number within 24 hrs