Transpyloric Stenting As a Predictor for G-POEM for Refractory Gastroparesis

Launched by NORTHWESTERN UNIVERSITY · Feb 26, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help people with a condition called gastroparesis, which means their stomach doesn't empty properly, leading to symptoms like nausea and bloating. The researchers want to see if a procedure called transpyloric stenting, where a special metal tube is placed in the stomach, can predict how well another treatment called G-POEM will work. G-POEM is designed to improve stomach emptying in patients who haven't responded to standard treatments. The study believes that if patients feel better after the stenting, they are more likely to benefit from the G-POEM procedure.

To participate, you need to be an adult over 18 years old with gastroparesis that hasn't improved with regular treatments or if you cannot take those treatments due to allergies. You should also have a confirmed diagnosis based on a specific test that measures how well your stomach empties. However, if you've had certain types of stomach surgery, have some cancers, or have serious health issues that make procedures unsafe, you may not be eligible. If you join the trial, you can expect close monitoring and support throughout the study to see how these treatments affect your symptoms.

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Eligibility criteria

• Inclusion Criteria:
• • Adult patients greater than 18 years of age with gastroparesis refractory to standard medical therapy (lifestyle and diet modifications, prokinetics) or contraindication to standard therapies (e.g. allergies to prokinetic agents)
• • Patients with diabetic, idiopathic or post-surgical gastroparesis
• • Patients with confirmed diagnosis of gastroparesis via gastric emptying study (abnormal gastric emptying will be defined as ≥10 % residual activity at 4 h on a standardized nuclear medicine TC-99 m sulfur colloid solid-phase gastric emptying study)
• Exclusion Criteria:
• • Patients with prior history of gastroenteric anastomosis or any GI surgeries with pyloric involvement
• • Patients with gastroesophageal malignancy
• • Patients who are unable to tolerate upper endoscopy secondary to cardiopulmonary instability or other contraindications to endoscopy
• • Patients with cirrhosis
• • Patients who are pregnant or breastfeeding
• • Patients with uncorrectable coagulopathy defined by INR \>1.5 or platelets \<50