Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gastroparesis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis: A Database Repository
Overview
Gastric Per-Oral Endoscopic Myotomy (G-POEM) is a procedure for the Treatment of Gastroparesis.
Detailed description
Gastroparesis is a disease of the stomach where there is significant delay in gastric emptying of contents to the intestines. This disease results in a multitude of symptoms including nausea, vomiting, weight loss, and malnutrition.
Current treatments for gastroparesis include dietary changes, oral medications (prokinetic agents to enhance gastric motility, acid reducers, anti-emetics to reduce nausea and vomiting), gastric stimulators and rarely surgery.
G-POEM (Gastric Per-Oral Endoscopic Myotomy-creating a cut in the muscle that controls gastric emptying), an incision-less (no cutting of the surface of the body) endoscopic procedure, is increasingly being performed to assist in the management of certain groups of patients with gastroparesis.
This data will be used for research purposes only to determine the clinical impact of endoscopic treatments on gastroparesis. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.
Primary outcome measures
- Assessment of Change in Gastroparesis Cardinal Symptom Index (GCSI) from baseline to post G-POEM [Time frame: 60 months span: baseline and assess change at 1 month, 3 month, 6 month, 12 month, 24 month, 36 month, 48 month & 60 months]
- Assessment of Change in Patient Assessment of gastrointestinal disorders-symptom severity index (PAGI-SYM) score from baseline to post G-POEM [Time frame: 60 months span: baseline and assess change at 1,3,6,12,24, 36,48 & 60 months]
- Assessment of Change in G-POEM SF-36 Health Survey score from baseline to post G-POEM [Time frame: baseline and assess change at 1,3,6,12,24,36,48 & 60 months]
- Assessment of change in Gastric Emptying Scan (GES) (solid phase, 4 hour study) from baseline to post G-POEM [Time frame: baseline; and assess change at 6, and 24 months]
Eligibility criteria
Inclusion criteria
- 18 years of age
- Referral for endoscopic treatment of Gastroparesis for symptom management
Exclusion criteria
- < 18 years of age
- Absence of gastroparesis based on scintigraphy studies
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Indiana University Hospital — Indianapolis
Publications
- Ichkhanian Y, Salame M, Wo JM, Nowak TV, Stainko S, Saito A, Siwiec RM, Kais A, Hwang JH, Li AA, Yang J, Broucek JR, Esfandyari T, Joseph S, Ujiki MB, Williams AE, Moremen J, Gouda Z, Schlachterman A, Hugova K, Martinek J, Geng CX, Podboy A, Wang AY, Lajin M, Gregor L, Miller PM, Al Bunni H, DeWitt JM, Al-Haddad M. A New International Scheme for the Classification and Management of Clinical Outcom PMID 40378985
- Salame M, Ichkhanian Y, Hadaki N, Wo JM, Stainko SA, Saito A, Siwiec RM, Nowak TV, Li A, Hwang JH, Yang J, Broucek J, Esfandyari T, Joseph S, Ujiki M, Williams AE, Moremen JR, Gouda Z, Schlachterman A, Hugova K, Martinek J, Geng CX, Podboy A, Wang AY, Lajin M, Miller P, Gregor L, Albunni H, Dewitt JM, Al-Haddad MA. Safety of same-day discharge after gastric peroral endoscopic myotomy in patients w PMID 39983999
Identifiers
NCT: NCT04434781 · 1708840627