Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

G-POEM for Treatment of Refractory Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02732821
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is performed to assess the efficacy and outcomes of Gastric Per Oral Endoscopic Myotomy "G-POEM" in patients presenting with gastroparesis.

Condition or disease Intervention/treatment
Diabetic Gastroparesis Idiopathic Gastroparesis Gastroparesis Postoperative Procedure: Gastric Per Oral Endoscopic Myotomy

Detailed Description:

Gastroparesis is a chronic digestive disorder best defined as severe nausea, vomiting, bloating, and abdominal pain in the setting of objectively delayed gastric emptying without mechanical gastric outlet obstruction. The most common etiology is idiopathic. Some of the identifiable etiologies include diabetes and post-surgical.

Endoscopic techniques to reduce pyloric tone mainly consisted of Botulinum toxin injection but failed to demonstrate significant symptom improvement compared to placebo. Another endoscopic method was transpyloric stenting which yielded symptomatic relief but is prone to stent migration and therefore is unlikely to provide a viable long term solution.

Surgical pyloroplasty has shown to be effective in reducing gastroparesis symptoms, but is associated with a risk of leakage and potential further narrowing of gastric outlet. It also carried all the risks of general anesthesia and requires advanced laparoscopic suturing skills. Therefore, the development of a less invasive reliable method of improving gastric emptying is highly desirable.

An endoscopic submucosal myotomy technique may be applied to divide the pyloric sphincter without surgical access. Such endoscopic technique may provide the benefits of a natural orifice procedure, and improve gastric emptying in gastroparetic patients. Gastric Per-Oral Endoscopic Myotomy (G-POEM) is feasible and can be performed by using techniques similar to those of esophageal per-oral endoscopic myotomy. Endoscopists who are experienced in esophageal per-oral endoscopic myotomy should be able to perform G-POEM because both use similar techniques, principles, and equipment.

The investigators theorize that a subset of patients with refractory gastroparesis, diabetic gastroparesis or post-surgical gastroparesis, may respond to endoscopic pyloromyotomy.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of the Efficacy and Outcomes of Gastric Peroral Endoscopic Myotomy (G-POEM) for Treatment of Refractory Gastroparesis
Actual Study Start Date : May 2015
Actual Primary Completion Date : April 2020
Actual Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Gastric Per Oral Endoscopic Myotomy
All patients presenting with Gastroparesis will undergo Per oral endoscopic gastric myotomy
 Procedure: Gastric Per Oral Endoscopic Myotomy
Patients will receive Per Oral Endoscopic Gastric Myotomy for Gastroparesis.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Efficacy of the G-POEM [ Time Frame: Up to 1 year ]

    Improvement in patients symptoms as evaluated by the Gastroparesis Cardinal Symptom Index (GCSI) at 1 month, 3 months, 6 months and 1 year.

    The GCSI consists of three sub-scales: nausea/vomiting (three items), post-prandial fullness/early satiety (four items) and bloating (two items). Each item is rated on a Likert scale ranging from 0 (none) to 5 (very severe). Subscales are the average of different sets of items and are reported as a number between 0 to 5.

    Efficacy will be defined as a decrease in the GCSI score average below 2.



Secondary Outcome Measures :
  1. Patient symptom improvement [ Time Frame: Up to 1 year ]

    Improvement in patients symptoms will be assessed using symptom severity score at 1 month, 3 months, 6 months and 1 year.

    Symptoms will be recorded with a standardized gastroesophageal symptom assessment tool using a scale of 0-4 with higher ordinal values representing the greater frequency of symptoms for nausea, vomiting, bloating, abdominal pain, Gastroesophageal Reflux Disease (GERD) symptoms.


  2. Delayed gastric emptying using a Gastric emptying study [ Time Frame: 3 months ]
    Assess efficacy of the G-POEM in the treatment of gastroparesis using gastric emptying study to assess delayed gastric emptying by measuring the average percentage of 4-hour gastric retention of a solid meal.

  3. Imapct of the G-POEM on patients' Quality of life [ Time Frame: Up to 1 year ]

    Improvement in patient's quality of life as reflected by Short Form 36 questionnaire at 1 month, 3 months, 6 months and 1 year after the procedure.

    The SF-36 general health questionnaire consists of 36 questions evaluating the patient's perception of their quality of life (QoL) in the following eight subscales: physical functioning (PF), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EW), social functioning (SF), bodily pain (BP) and general health (GH). Subscale scores range from 0 to 100, with 100 being the best and 0 being the worst quality of life.


  4. Efficacy of the G-POEM [ Time Frame: 1 year ]

    Improvement in patients symptoms as evaluated by gastroparesis specific symptom assessment (PAGI-SYM questionnaire).

    PAGI-SYM is a 20-item self-reported questionnaire which evaluates the symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain and heartburn/regurgitation). These are summarized by individual subscale scores and a total score. Each item is rated on a Likert scale ranging from 0 (none) to 5 (very severe). Subscales are the average of different sets of items and are reported as a number between 0 to 5.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals who initially approach the study team from outside the institution (e.g. responding to the clinicaltrials.gov listing) or patients seen in the gastroenterology clinic.
Criteria

Inclusion Criteria:

• Adult patient age greater than 18 years old who are undergoing a standard-of-care G-POEM procedure.

Exclusion Criteria:

  • Previous surgery of the esophagus or stomach which has resulted in a resection of the antrum and pylorus
  • Known active gastroesophageal malignancy
  • Prior surgical or laparoscopic pyloromyotomy
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732821


Locations
Layout table for location information
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Mouen A Khashab, MD Johns Hopkins University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02732821    
Other Study ID Numbers: IRB00066924
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Johns Hopkins University:
Gastroparesis
G-POEM
Gastric Per Oral Endoscopic Myotomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Paralysis
Neurologic Manifestations