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Completed

NCT Number: NCT02732821

G-POEM for Treatment of Refractory Gastroparesis

This study is performed to assess the efficacy and outcomes of Gastric Per Oral Endoscopic Myotomy "G-POEM" in patients presenting with gastroparesis.

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Key information

Conditions

Diabetic Gastroparesis Digestive System Diseases Gastrointestinal Diseases Gastroparesis Gastroparesis Postoperative Idiopathic Gastroparesis Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric Per Oral Endoscopic Myotomy

Procedure

Patients will receive Per Oral Endoscopic Gastric Myotomy for Gastroparesis.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Observational Study of the Efficacy and Outcomes of Gastric Peroral Endoscopic Myotomy (G-POEM) for Treatment of Refractory Gastroparesis

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 11, 2016
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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