Table 10.
Efficacy of G-POEM for gastroparesis based on open-label studies.
| # Pts | Types of gastroparesis pts | Changes in GE | Changes in symptoms | Duration follow up | Adverse events | Ref. # |
|---|---|---|---|---|---|---|
| 29 | DG=7 IG= 15 PSG=5 scleroderma=2 |
70% Normalized | 79% at 3 months; 69% at 6 months. GCSI improved from 3.5 to 0.9 at 3 months | 3 and 6 months | 17% (2/12) Pneumoperitoneum requiring decompression | Gonzalez 2017, ref. 163 |
| 16 | DG=9 IG=5 PSG=1 post-infectious = 1 |
75% normalized, 25% improved | 81% improvement. GCSI improved from baseline of 3.4 to 1.46 12 months later | 12 months | None | Dacha 2017, ref. 164 |
| 47 | DG=12 IG=27 PSG=8 |
4h retention improved: from 37.2 to 20.4% | GCSI improved from 4.6 to 3.3 | 3 months (follow-up in 31/47 pts) | 1 death (unrelated) | Rodriguez 2017, ref. 165 |
| 30 | DG=11 IG=7 PSG=12 |
47% Normalized | No validated outcome measure available | 6 months | 2/30 (6%): 1 pre-pyloric ulcer and 1 capnoperitoneum | Khashab 2017, ref. 166 |
| 13 | DG=1 IG=4 PSG=8 |
4/6 improved; % retention at 4h improved from 49 to 33% | In 11: 4 considerably better, 4 somewhat better, 1 no Δ, 2 worse | 3 months | 3 accidental mucosotomy closed with clips; 1 pulmonary embolism | Malik 2018, ref. 167 |
| 16 | DG=3 PSG=13 |
Mean % retention (radiolabeled bread) at 2h from 69.3% to 33.4% | Mean total symptom score from 24.25 to 6.37; 13/16 substantial improvement | 3 months | 1 pyloric stenosis at day 45 | Xu 2018, ref. 168 |
| 20 | DG=10 non-diabetic=10 |
% retention at 4h improved from 57.5 to 15%; and 30% normalized | GCSI improved from 3.5 to 1.3; QOL improved | 3 months | 3 mild hemorrhage, 3 gastric perforation, 1 moderate dyspepsia | Jacques 2019, ref. 169 |
| 40 | DG=15 Nondiabetic=25 (of which 18 were IG) |
% retention at 4h reduced by 41.7% | Improved GCSI, nausea/vomiting, not bloating | median 15 months | 1 tension capnoperitoneum, 1 exacerbation of COPD; 1 (Ehlers-Danlos syndrome) disrupted mucosotomy + ulcer | Mekaroonkamol 2019, ref. 170 |
| 22 | DG=8, IG=14, all with GES and most with diverse other procedures | In 7/11 with post-G-POEM, GE was normal | GCSI improved (reduction 1.63 points); improved all sub-scores | 1 and 3 months | 1 laparoscopy for pain due to capnoperitoneum and adhesions | Strong 2019, ref. 171 |
| 38 | PSG (76% for fundoplication or hiatal hernia repair) | % retention at 4h improved from 46.4 to 17.9%; 50% normalized | GCSI improved (mean reduction 1.29 points); improved all subscores | 1 month | 2 readmissions: 1 melena; 1 dehydration | Strong 2019, ref. 172 |
| 80 | IG (41.3%), PSG (35%) and DG (23.8%). | GE scintigraphy improvement in 64.2% and normalized in 47.2% (of 53 cases with test) at 3 months | Decrease in total GCSI >1 + >25% decrease in at least two of the subscales in 66.6% at 12 months | 3 months GES, 12 months clinical | 3 symptomatic capnoperitoneum, 1 mucosotomy; 1 thermal mucosal injury | Vosoughi 2021, ref. 173 |
| 9 | 5 PSG, 2 DG, 1 IG, and 1 PSG and diabetic | Mean GSCI decreased from 3.16 to 0.86 (3 months), 0.74 (6 months), 1.07 (12 months) and 1.31 (24 months [ns]) after the procedure. GIQLI improved from baseline at 12 months; not significant at 24 months | median follow-up was 23 (range 12–31) months | 1 delayed bleeding from gastric ulcer | Hustak 2020, ref. 174 | |
| 76 | Gastroparesis with median duration 48 months; median gastric retention at 4h 45% and median GCSI 3.6 | High rate of gastric retention at 4h was significantly associated with clinical failure | Clinical success in 65.8% of patients at 1 year, with median of reduction in GCSI score of 41 %; high preop GCSI satiety score predicted clinical success | At least 1 y | Ragi 2021, ref. 175 | |
| SRMA | 14 studies with total 276 patients | Pooled GE scintigraphy normalization rate was 61.3% (95% CI, 51.5–70.8%) | Clinical symptom improvement rate was 88.2% (95% CI, 83.6–93.1%). Mean GCSI score improvement rate: 90.2% at 1 month, 83.3% at 3 months, 70.3% at 6months, 52.4% at 12 months and 57.1% at 18 months. |
Up to 18 months | Intra-operative complications were found in about 3.2% and postoperative adverse events in 2.1% | Zhang 2019, ref. 176 |
| SRMA | 6 studies | GE scintigraphy not improved | Improvement in GCSI score after 3 months of G-POEM as compared with pre-G-POEM GCSI scores. | 3 months | Pooled rate of total adverse events was 9% (95% C.I. 2.7–25.9). | Garg 2020, ref. 177 |
| SRMA | 272 patients in 8 studies | The pooled results of 4h GE scintigraphy were 41.89% (95% CI, 32.75–51.03%) pre-G-POEM and 16.48% (95% CI, 9.83–23.14%) post-G-POEM | Pooled rates of GCSI were 3.25 (95% CI, 2.75–3.75) pre-procedure, 1.80 (95% CI, 1.10–2.49) at 1–3 months, 1.56 (95% CI, 0.45–2.68) at 6 months, and 1.10 (95% CI, 0.75–1.45) at 12 months | 1, 3, 6, and 12 months | Pooled adverse events rate was 12% (95% CI, 6–19%) | Li 2021, ref. 178 |
| SRMA | 10 studies, 292 patients | GE scintigraphy, significant decrease of the residual percentage at 2 and 4 hours | Significant symptomatic improvement was achieved after 83.9% of procedures | Mean follow-up, 7.8 ± 5.5 months). | The overall adverse events rate was 6.8%. | Spadaccini 2020, ref. 179 |
| Laparoscopic pyloroplasty compared to G-POEM procedure | ||||||
| 60 | Retrospective comparison lap pyloroplasty (LP) vs. G-POEM, Single-center, 30 per group (19 IG, 6 PSG, 5 DG), matched by propensity scoring | LP and G-POEM both resulted in similar, significant improvements in GCSI scores (overall and each of 3 subscales) with no differences between treatment groups | LP and G-POEM both resulted in similar, significant improvements in objective GE with no differences between treatment groups | 1-month outcome (28 G-POEM, 22 LP) 3-month outcome (25 G-POEM, 21 LP) |
Longer length of stay, operative time, more estimated blood loss and complications in the LP group (surgical site infection, pneumonia, and unplanned ICU admission | Landreneau 2019, ref. 180 |
| SRMA | G-POEM (332 in 11 studies) vs. surgical pyloroplasty (375 in 7 studies | 4h GE scintigraphy success results: G-POEM 85.1% (95% CI 68.9–93.7) and surgical pyloroplasty 84% (95% CI 64.493.8) with no significant difference | Clinical success, based on GCSI score: G-POEM 75.8% (95% CI 68.1–82.1) and surgical pyloroplasty 77.3% (95% CI 66.4–85.4), with no significant difference |
Overall adverse events were comparable | Mohan 2020, ref. 181 | |
DG=diabetic gastroparesis; GCSI=Gastroparesis Cardinal Symptom Index; GE=gastric emptying; GIQLI=Gastrointestinal Quality of Life Index; IG=idiopathic gastroparesis; LP=laparoscopic pyloroplasty; PSG=post-surgical gastroparesis; QOL=quality of life; SRMA=systematic review and meta-analysis; TSS=total symptom score; XO=crossover