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G-POEM for Treatment of Refractory Gastroparesis

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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

Tracking Information
First Submitted Date March 30, 2016
First Posted Date April 11, 2016
Last Update Posted Date August 21, 2020
Actual Study Start Date May 2015
Actual Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 3, 2018)
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.
Original Primary Outcome Measures
 (submitted: April 4, 2016)
Efficacy of the G-POEM [ Time Frame: Up to 2 years ]
Improvement in patients symptoms as evaluated by the Gastroparesis Cardinal Symptom Index at 1 month, 6 months, 1 year, and 2 years.
Change History
Current Secondary Outcome Measures
 (submitted: January 8, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: April 4, 2016)
  • Patient symptom improvement [ Time Frame: Up to 2 years ]
    Improvement in patients symptoms will be assessed using symptom severity score at 1 month, 6 months, 1 year, and 2 years.
  • 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
  • Quality of life [ Time Frame: Up to 2 years ]
    Improvement in patient's quality of life as reflected by Short Form-36 questionnaire at 1 month, 6 months, 1 year, and 2 years after the procedure
  • Efficacy of the G-POEM [ Time Frame: 2 years ]
    Improvement in patients symptoms as evaluated by gastroparesis specific symptom assessment (pagi-sym)
  • Distensibility of pyloric sphincter using Endoluminal functional lumen imaging probe (EndoFLIP) [ Time Frame: 3 months ]
    This will be measured immediately post-procedure and at 3 months.
  • Postoperative hospitalizations. [ Time Frame: Up to 2 years ]
  • Use of Prokinetic medication [ Time Frame: Up to 2 years ]
    Patient will be called and asked for use of prokinetic medications at 1 month, 6 months, 1 year and 2 years.
  • Post-operative emergency visits [ Time Frame: Up to 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title G-POEM for Treatment of Refractory Gastroparesis
Official Title Observational Study of the Efficacy and Outcomes of Gastric Peroral Endoscopic Myotomy (G-POEM) for Treatment of Refractory Gastroparesis
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Diabetic Gastroparesis
  • Idiopathic Gastroparesis
  • Gastroparesis Postoperative
Intervention Procedure: Gastric Per Oral Endoscopic Myotomy
Patients will receive Per Oral Endoscopic Gastric Myotomy for Gastroparesis.
Study Groups/Cohorts Gastric Per Oral Endoscopic Myotomy
All patients presenting with Gastroparesis will undergo Per oral endoscopic gastric myotomy
Intervention: Procedure: Gastric Per Oral Endoscopic Myotomy
Publications * Vosoughi K, Ichkhanian Y, Benias P, Miller L, Aadam AA, Triggs JR, Law R, Hasler W, Bowers N, Chaves D, Ponte-Neto AM, Draganov P, Yang D, El Halabi M, Sanaei O, Brewer Gutierrez OI, Bulat RS, Pandolfino J, Khashab M. Gastric per-oral endoscopic myotomy (G-POEM) for refractory gastroparesis: results from an international prospective trial. Gut. 2021 Mar 19. pii: gutjnl-2020-322756. doi: 10.1136/gutjnl-2020-322756. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 19, 2020)
80
Original Estimated Enrollment
 (submitted: April 4, 2016)
30
Actual Study Completion Date April 2020
Actual Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02732821
Other Study ID Numbers IRB00066924
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators Not Provided
Investigators
Principal Investigator: Mouen A Khashab, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date August 2020