D0442 - Minimal Clinically Important Differences in Overall and Individual Gastroparesis Symptoms After G-POEM: Impact of Clinical Factors and Prior Treatments

Tuesday, October 25, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

TJ

Terry Jue, MD

Mayo Clinic Arizona
Scottsdale, AZ

Terry Jue, MD¹, William Hasler, MD¹, Tiffany Chua, MD¹, Lucinda A. Harris, MS, MD², Tisha Lundsford, MD¹, Norio Fukami, MD¹
¹Mayo Clinic Arizona, Scottsdale, AZ; ²Mayo Clinic, Alix School of Medicine, Scottsdale, AZ

Introduction: Gastric peroral endoscopic myotomy (G-POEM) reduces symptoms in gastroparesis to varying degrees. Studies using Gastroparesis Cardinal Symptom Index (GCSI) surveys set cutoffs for minimal clinically important differences (MCID) that reflect significant longitudinal improvement over time. Few studies have assessed MCIDs of individual gastroparesis symptoms after G-POEM or impact of clinical factors on MCID responses. We compared MCIDs to G-POEM for overall and individual symptoms relating to gastric emptying, pain and opioid use, conditions associated with gastroparesis, and prior therapy.

Methods: 22 refractory gastroparesis patients completed GCSI surveys (0=no symptoms, 5=very severe) before and 85+64 days after G-POEM from 2017-21. MCIDs >1 after G-POEM were deemed significant for overall GCSI and individual nausea/vomiting (NV), early satiety/fullness (ES), and bloating/distention (BL) scores.

Results: 11/22 patients (50%) met MCID cutoffs for significant GCSI decrease after G-POEM. Individual symptom decreases meeting MCID cutoffs were seen in 12 patients for NV and ES (54%) and 9 for BL (41%). NV and ES reductions were greater in those meeting GCSI MCID cutoffs; BL reductions trended higher (Figure). Gastric emptying normalized in 8/20 patients (40%) which was not different in MCID responders vs. nonresponders for GCSI (44 vs. 36%, P=1.0), NV (30 vs. 50%, P=0.65), ES (40 vs. 40%, P=1.0), or BL (56 vs. 27%, P=0.46). Pain as a major symptom was noted by 2/10 responders (20%) vs. 4/11 nonresponders (36%)(P=0.64). Opioids were used by 3/11 responders and 3/11 nonresponders (27%, P=1.0). Higher basal symptoms, associated IBS and fibromyalgia, and therapies (opioids, metoclopramide, botulinum toxin) impacted responses (Table).

Discussion: Important overall symptom responses to G-POEM using MCIDs were reported by half of gastroparesis patients. Individual symptoms of nausea/vomiting and early satiety showed meaningful decreases more often than bloating. MCID responses did not relate to gastric emptying or pain as a major symptom, but opioid use weakly predicted reduced early satiety/fullness. Increased basal gastroparesis symptoms and IBS related to greater response; fibromyalgia weakly predicted lower response. Metoclopramide use predicted response while higher numbers of botulinum toxin injections weakly related to lesser response raising concerns about pyloric scarring. These findings may be considered in selecting patients for G-POEM.

Figure: Individual symptom reductions in nausea/vomiting and early satiety/fullness in patients showing MCID responses in overall GCSI to G-POEM were greater than nonresponders. Bloating/distention improvements trended greater.

Symptom Score Measuring MCID Response	Associated with Improved Response		Associated with Poorer Response
Symptom Score Measuring MCID Response	Factor	P Value	Factor	P Value
Overall GCSI score	Higher basal individual postprandial fullness score	0.04	Higher number of botulinum toxin injections	0.08
Overall GCSI score	Prior metoclopramide use	0.08	Higher number of botulinum toxin injections	0.08
Nausea/vomiting GCSI subscore	Higher basal NV GCSI subscore	0.03	Diabetic gastroparesis etiology	0.09
	Higher basal individual nausea score	0.02	Fibromyalgia	0.09
	Higher basal individual vomiting score	0.03
Early satiety/fullness GCSI subscore	Higher basal NV GCSI subscore	0.03	Fibromyalgia	0.06
	Higher basal ES GCSI subscore	0.01	Fibromyalgia	0.06
	Higher basal individual postprandial fullness score	0.001	Prior opioid use	0.06
	Prior metoclopramide use	0.01	Prior opioid use	0.06
Bloating/distention GCSI subscore	IBS	0.04

Disclosures:

Terry Jue indicated no relevant financial relationships.

William Hasler indicated no relevant financial relationships.

Tiffany Chua indicated no relevant financial relationships.

Lucinda Harris: AbbVie – Advisory Committee/Board Member. Allakos – Grant/Research Support. Alnylam – Advisory Committee/Board Member. Ardelyx – Advisory Committee/Board Member. Gemelli Biotech – Advisory Committee/Board Member. Ironwood – Consultant. Salix – Advisory Committee/Board Member. takeda – Grant/Research Support.

Tisha Lundsford indicated no relevant financial relationships.

Norio Fukami indicated no relevant financial relationships.

Terry Jue, MD¹, William Hasler, MD¹, Tiffany Chua, MD¹, Lucinda A. Harris, MS, MD², Tisha Lundsford, MD¹, Norio Fukami, MD¹. D0442 - Minimal Clinically Important Differences in Overall and Individual Gastroparesis Symptoms After G-POEM: Impact of Clinical Factors and Prior Treatments, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.