Outcomes of per oral endoscopic pyloromyotomy in gastroparesis worldwide

Table 1 Clinical outcomes of per oral endoscopic pyloromyotomy

	Type	N	Etiology of gastroparesis	Definition of refractory gastroparesis	Average Procedure duration (min)	Outcome measurement	Clinical response definition	Clinical response rate N (%)	GCSI improvement	Subscale	Adverse event	Follow-up period (mo) (Additional treatment during follow up)
Shlomovitz et al[37]	Retrospective	7	2 PSG; 4 IG; 1 patient with normal GES	Not defined	90-120	GES (3M) ; Gastroparesis; Symptoms	Symptomatic improvement	85.7%	NA	Nausea and epigastric burn significantly improved	One prelyloric ulcer with GI bleed	6.5 (2-11) (1 patient required Laparoscopic pyloroplasty at 7 mo, also no response after the procedure)
Chung et al[41]	Retrospective	8	4 DG; 4 PSG	Not defined		GOOSS; GES	NA	NA	NA	Nausea; Vomiting; Abdominal pain	1 bleeding pre-pyloric ulcer; 1 dumping syndome	7
Khashab et al[45]1	Retrospective	30	11 DG; 12 PSG; 7 IG	Presence of symptoms despite dietary; Modification and treatment with prokinetics and antiemetics	72 ± 42	GES (3M); Gastroparesis Symptoms (Graded self-reported symptomatic responses: Resolved, improved, unchanged or worse)	Reduction in gastroparesis symptoms with absence of recurrent hospitalization	86%	NA	97% improve nausea; 63% improve in vomiting; 73% improve in abd pain; 93% maintain or gain weight	6.7% 1 capnoperitonum; 1 prepyloric ulcer	5.5
Gonzalez et al[2] France	Retrospective	29	7 DG 5 PSG; 15 IG; 2 Other (Scleroderma)	Symptoms > 6 mo despite Rx and fail “all” prokinetic drug, GCSI > 1.5	47	GES (2M); GCSI	Improvement in GCSI and GES	79% (3M); 69% (6M)	3.3 to 1.1	All GCSI	5 pneumoperitoneum; 2 Bleeding; 1 perigastric abscess (patient ate 2 h post-procedure) 1 delayed pre-pyloric stricture	6
Dacha et al[43]	Retrospective	16	9 DG; 1 PSG; 5 IG; 1 PIG	Patients who failed to respond to dietary modification, prokinetic medication, or electrical stimulator	49.7 ± 22.1	GES; GCSI; SF36	A decrease in mean GCSI with an improvement of at least 2 subsets of cardinal symptoms and no gastroparesis -related hospitalization	81%	3.4 to 1.5	N/V and early satiety significantly improved but not bloating	none	12
Rodriguez et al[48]	Prospective observation	47	12 DG; 8 PSG; 27 IG	Patients with ongoing symptoms after at least 6 mo of medical therapy	41.2 ± 28.5	GES; GCSI	improvement in post-procedure GCSI, a decrease in the total number of gastroparesis medications used, and improved GES at 90-day	Not reported	3.6 to 3.3	All 3 subscales were significantly improved but N/V and bloating improved the most	none	3 (1 pt had lap total gastrectomy at 9 mo)
Allemang et al[55]	Retrospective	57	Not reported	Not clearly defined	41	GCSI	Improved GCSI	Not reported	4.6 to 3.3	Not reported	Not reported	3
Malik et al[47]	Case series	13	1 DG; 8 PSG; 4 IG	Not clearly defined	± 23	GES; PAGI-SYM; EndoFLIP	Improved GCSI, CPGAS, and GES	72.7%	2.1 to 1.9	Vomiting, retching, and loss of appetite improved the most by 29, 24, and 24%. None was statistically significant; Abd distension was actually worse	1 pulm embolism	3
Mekaroonkamol et al[62]	Retrospective	30	12 DG; 5 PSG; 12 IG; 1 PIG	Patients who failed to respond or could not tolerate to dietary modification, prokinetic medication, or electrical stimulator	48.3 ± 16.5	GES (2M); GCSI; SF36; ER visit rate; Hospitalization rate	Decrease in at least 1 averaged point of GCSI with more than a 25% decrease in at least 2 subscales > 25% increase in the mean SF-36 score with at least 50% increase in 3 categories	83.3%	3.6 to 1.4	Nausea and early satiety significantly improved; Pain only improved up to 6 mo but not thereafter	1 tension capnoperitoneum (3.3%)	18
Jacques et al[61]	Prospective	20	10 DG; 1 PSG; 4 IG; 5 Other (including 3 Sjogen, 1 Parkinson’s, and 1 systemic sclerosis	Symptoms > 6 mo despite medication, GCSI > 2.6 OR refractory vomiting, uncontrolled post-prandial hypoglycemia, need for oral medication, Fail at least 2 out of 3 prokinetic drug	56.5	GES (3M); GCSI; PAGI-QoL; GIQLI; EndoFlIP; Abdominal pain score	A decrease of more than 0.75 point of GCSI	90%	3.5 to 1.3	All 9 subscale of GCSI except for retching	4 perforation, including 1 required surgical intervention1 case of epitaxis	3
Kahaleh et al[58]2	Retrospective	33	7 DG; 12 PSG; 13 IG; 1 Other	Not clearly defined	77.6 (37-255)	GES; GCSI	Improvement in GCSI and GES	85%	3.3 to 0.8	All subscale including abd pain significantly improved	1 bleeding and 1 ulcer	11.5
Hustak et al[59]2	Prospective	7	2 DG; 4 PSG; 1 IG	Not clearly defined	70	GES; GCSI	Improvement in GCSI of > 40% and GES	100%	3.26 to 1.24	Not reported	1 bleeding ulcer	12
Mekaroonkamol et al[62]2	Retrospective	40	15 DG; 5 PSG; 18 IG; 1 PIG; 1 Other (Ehlers Danlos)	Patients who failed to respond or could not tolerate to dietary modification, prokinetic medication, or electrical stimulator	Not reported	GES (2M); GCSI; SF36	Decrease in at least 1 averaged point of GCSI with more than a 25% decrease in at least 2 subscales	Not reported	3.6 to 1.9	Only nausea/vomiting and early satiety improved, but not for bloating	1 capnoperiteum; 1 COPD exacerbation; 1 myotomy dehiscence	18

¹Multicenter trial, two centers in the United States were involved.

²Abstract only publications.

DG: Diabetic gastroparesis; PSG: Post-surgical gastroparesis; IG: Idiopathic gastroparesis; PIG: Post-infectious gastroparesis; GES: Gastric emptying scintigraphy; GCSI: Gastroparesis cardinal symptoms index; GOOSS: Gastric outlet obstruction scoring system; SF36: Short form 36; PAGI-SYM: Patient Assessment of Gastrointestinal Symptoms; N/V: Nausea and vomiting; EndoFLIP: Endoscopic functional luminal imaging probe; CPGAS: Clinical Patient Grading Assessment Score; COPD: Chronic obstructive pulmonary disease.