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176 PerOral Endoscopic Myotomy: a Meta-Analysis
Abstracts Table 1. Indications for surgery in patient with BD-IPMN based on
International consensus guidelines 2012 for the management of BD-IPMN of the pancreas Indications High-risk stigmata on CT/MRI (n, %) - MPD diameter R 10 mm - Enhanced solid component Worrisome features on CT/MRI (n, %) - MPD size 5-9 mm - Cyst size R 30 mm - Thickened enhanced cyst walls - Non-enhanced mural nodules - Abrupt change in the MPD caliber with distal pancreatic atrophy - Lymphadenopathy Features on EUS-FNA (n, %) - Definite mural nodules - MPD features suspicious for involvement* - Suspicious/positive cytology for malignancy
Benign (n[117)
Malignant (n[18)
P value
2 (2) 3 (3)
0 1 (5)
1.00 1.00
9 (50) 5 (28) 1 (5) 1 (5) 0
0.01 1.00 1.00 1.00
21 33 2 2
(18) (28) (2) (2) 0 0
0
6 (6) 9 (8) 8 (7)
5 (28) 5 (28) 4 (22)
0.01 0.01 0.04
*Presence of any of the following criteria: thickened walls, intraductal mucin or mural nodules is suggestive of MPD involvement Table 2. EUS features and cyst fluid analysis in patients with BD-IPMN
who underwent surgery (n[105) Cyst characteristics Mean cyst size (SD) (cm) Mean MPD size (SD) (mm) Increasing cyst size (n, %) - Increased mean size (SD) (mm) - Mean time to increase size (SD) (months) Locations (n, %) - Proximal pancreas (Uncinate, Head and Neck) - Distal pancreas (Body and tail) - Multifocal in proximal and distal Multifocal lesions (n, %) Mural nodules (n, %) Mean mural nodule size (SD) (mm) Thick cyst wall (n, %) Solid component (n, %) Septations (n, %) Calcification (n, %) Internal debris (n, %) Associated benign appearing lymphadenopathy Cystic fluid analysis of clinical indicators - Amylase (median, range) (U/L) - CEA (median, range) (ng/mL) - Cytology suspicious/positive for malignancy (n, %) Cystic fluid analysis of molecular indicators (n, %) - Elevated DNA quantity - Poor DNA quality - KRAS point mutation - Tumor suppressor genes (LOH)
Benign (n[91)
Malignant (n[14)
P value
2.92.5 3.31.5 13 (14) 14.17.1 19.820.6
1.20.7 8.52.1 2 (14) 27.517.7 12.317.0
0.26 !0.001 1.00 0.47 0.64
61 (67)
8 (57)
33 (36) 23 (25) 35 (38) 6 (6) 1.73.2 4 (4) 3 (3) 33 (36) 1 (1) 4 (4) 5 (5)
4 (29) 6 (43) 3 (21) 5 (36) 3.74.1 0 0 2 (14) 0 0 0
2482 (52300000) 277 (0.5198960) 8 (9)
5015 (24644567) 261.15 (13.2221149) 4 (29)
0.76
30 (33)
5 (36)
0.74
4 21 16 2
1 (7) 4 (29) 1 (7) 1 (7)
1.00 1.00 0.20 0.90
included PubMed, CINAHL, EMBASE, and OVID for peroral endoscopic myotomy for all dates until 10/2014, excluding case reports. Outcomes included Eckardt score, manometric and radiologic parameters, weight change, and complication rate. Working independently and in parallel, two reviewers screened references. Results were combined using a random-effects model. Heterogeneity was assessed with Isquared, and publication bias with Egger’s test. Results: Data was extracted from 68 publications from 2011-2014 (35.4% full-text, 64.6% abstract), with 3,835 procedures from 2008-2014. 53% of patients were female (age 457y). Major indication was achalasia (O98%), other indications were diffuse esophageal spasm, jackhammer esophagus, non-relaxing lower esophageal sphincter (LES), and nutcracker esophagus. Presenting symptoms were dysphagia (81%), chest pain (45%), and reflux (51%). 29 cases (!1%) were not completed (submucosal tunneling failure due to severe inflammation or fibrosis). Procedure duration was 8132 min, and postprocedure stay was 3.51.7d. Primary assessment of clinical success was Eckardt score %3, in 97% (95% CI 96-98%) without significant heterogeneity (I2Z0.1%, pZ0.47). Pre-POEM Eckardt score was 7.10.92. This decreased to 0.920.46, 1.10.65, and 1.20.35 at 1, 6, and 12 months. Pre-POEM manometric LES resting (338.6 mmHg) and 4s integrated relaxation pressure (IRP) (275.4 mmHg). These decreased to 13.94.2mmHg and 135.4mmHg within 6 months. Meta-analysis yielded significant decrease of LES resting (19 mmHg (95% CI 16-22)) and 4s IRP (14mmHg (95% CI 13-16)). Pre-POEM barium esophagogram column height was 154 cm (1 min) and 103.4 (5 min), reducing to 4.41.7cm (1 min) and 2.61.4cm (5 min) within 6 months. Meta-analysis yielded significant decrease of 11cm (95% CI 7-15) (1 min) and 6.8cm (95% CI 5.7-7.9) (5 min). Weight gain was 61.3 kg within 6 months. Significant GERD occurred in 14% (95% CI 5.2-27%) within 1 month and 13% (95% CI 8.7-18%) between 1-6 months post-POEM. Intraprocedure complications included mucosal injury (9.9%), esophageal perforation (0.8%), and bleeding requiring intervention (0.5%). Post-POEM complications included subcutaneous emphysema (22%), subclinical pneumothorax (5.6%), pneumomediastinum (18%), pneumoperitoneum (24%), pleural effusion (17%), and focal atelectasis (12%). Conclusion: POEM appears safe and effective in this meta-analysis, which included a large number of patients with low heterogeneity. Standardized training programs should be better developed to encourage safe adoption of this technique.
0.70
(4) (23) (17) (2)
0.59 0.01 0.02 0.68 1.00 0.34 1.00 1.00 1.00
0.37 0.04
Figure 1. POEM meta-analysis results
176 PerOral Endoscopic Myotomy: a Meta-Analysis Emmanuel Akintoye*, Nitin Kumar, Christopher C. Thompson Division of Gastroenterology, Brigham & Women, Boston, MA Background: Peroral endoscopic myotomy (POEM) allows endoscopic therapy of achalasia. Given the less invasive nature of this technique compared to traditional surgical approaches it is becoming more popular. Aim To evaluate the medical literature to determine the safety and efficacy of POEM. Methods: The search
AB116 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
www.giejournal.org
International consensus guidelines 2012 for the management of BD-IPMN of the pancreas Indications High-risk stigmata on CT/MRI (n, %) - MPD diameter R 10 mm - Enhanced solid component Worrisome features on CT/MRI (n, %) - MPD size 5-9 mm - Cyst size R 30 mm - Thickened enhanced cyst walls - Non-enhanced mural nodules - Abrupt change in the MPD caliber with distal pancreatic atrophy - Lymphadenopathy Features on EUS-FNA (n, %) - Definite mural nodules - MPD features suspicious for involvement* - Suspicious/positive cytology for malignancy
Benign (n[117)
Malignant (n[18)
P value
2 (2) 3 (3)
0 1 (5)
1.00 1.00
9 (50) 5 (28) 1 (5) 1 (5) 0
0.01 1.00 1.00 1.00
21 33 2 2
(18) (28) (2) (2) 0 0
0
6 (6) 9 (8) 8 (7)
5 (28) 5 (28) 4 (22)
0.01 0.01 0.04
*Presence of any of the following criteria: thickened walls, intraductal mucin or mural nodules is suggestive of MPD involvement Table 2. EUS features and cyst fluid analysis in patients with BD-IPMN
who underwent surgery (n[105) Cyst characteristics Mean cyst size (SD) (cm) Mean MPD size (SD) (mm) Increasing cyst size (n, %) - Increased mean size (SD) (mm) - Mean time to increase size (SD) (months) Locations (n, %) - Proximal pancreas (Uncinate, Head and Neck) - Distal pancreas (Body and tail) - Multifocal in proximal and distal Multifocal lesions (n, %) Mural nodules (n, %) Mean mural nodule size (SD) (mm) Thick cyst wall (n, %) Solid component (n, %) Septations (n, %) Calcification (n, %) Internal debris (n, %) Associated benign appearing lymphadenopathy Cystic fluid analysis of clinical indicators - Amylase (median, range) (U/L) - CEA (median, range) (ng/mL) - Cytology suspicious/positive for malignancy (n, %) Cystic fluid analysis of molecular indicators (n, %) - Elevated DNA quantity - Poor DNA quality - KRAS point mutation - Tumor suppressor genes (LOH)
Benign (n[91)
Malignant (n[14)
P value
2.92.5 3.31.5 13 (14) 14.17.1 19.820.6
1.20.7 8.52.1 2 (14) 27.517.7 12.317.0
0.26 !0.001 1.00 0.47 0.64
61 (67)
8 (57)
33 (36) 23 (25) 35 (38) 6 (6) 1.73.2 4 (4) 3 (3) 33 (36) 1 (1) 4 (4) 5 (5)
4 (29) 6 (43) 3 (21) 5 (36) 3.74.1 0 0 2 (14) 0 0 0
2482 (52300000) 277 (0.5198960) 8 (9)
5015 (24644567) 261.15 (13.2221149) 4 (29)
0.76
30 (33)
5 (36)
0.74
4 21 16 2
1 (7) 4 (29) 1 (7) 1 (7)
1.00 1.00 0.20 0.90
included PubMed, CINAHL, EMBASE, and OVID for peroral endoscopic myotomy for all dates until 10/2014, excluding case reports. Outcomes included Eckardt score, manometric and radiologic parameters, weight change, and complication rate. Working independently and in parallel, two reviewers screened references. Results were combined using a random-effects model. Heterogeneity was assessed with Isquared, and publication bias with Egger’s test. Results: Data was extracted from 68 publications from 2011-2014 (35.4% full-text, 64.6% abstract), with 3,835 procedures from 2008-2014. 53% of patients were female (age 457y). Major indication was achalasia (O98%), other indications were diffuse esophageal spasm, jackhammer esophagus, non-relaxing lower esophageal sphincter (LES), and nutcracker esophagus. Presenting symptoms were dysphagia (81%), chest pain (45%), and reflux (51%). 29 cases (!1%) were not completed (submucosal tunneling failure due to severe inflammation or fibrosis). Procedure duration was 8132 min, and postprocedure stay was 3.51.7d. Primary assessment of clinical success was Eckardt score %3, in 97% (95% CI 96-98%) without significant heterogeneity (I2Z0.1%, pZ0.47). Pre-POEM Eckardt score was 7.10.92. This decreased to 0.920.46, 1.10.65, and 1.20.35 at 1, 6, and 12 months. Pre-POEM manometric LES resting (338.6 mmHg) and 4s integrated relaxation pressure (IRP) (275.4 mmHg). These decreased to 13.94.2mmHg and 135.4mmHg within 6 months. Meta-analysis yielded significant decrease of LES resting (19 mmHg (95% CI 16-22)) and 4s IRP (14mmHg (95% CI 13-16)). Pre-POEM barium esophagogram column height was 154 cm (1 min) and 103.4 (5 min), reducing to 4.41.7cm (1 min) and 2.61.4cm (5 min) within 6 months. Meta-analysis yielded significant decrease of 11cm (95% CI 7-15) (1 min) and 6.8cm (95% CI 5.7-7.9) (5 min). Weight gain was 61.3 kg within 6 months. Significant GERD occurred in 14% (95% CI 5.2-27%) within 1 month and 13% (95% CI 8.7-18%) between 1-6 months post-POEM. Intraprocedure complications included mucosal injury (9.9%), esophageal perforation (0.8%), and bleeding requiring intervention (0.5%). Post-POEM complications included subcutaneous emphysema (22%), subclinical pneumothorax (5.6%), pneumomediastinum (18%), pneumoperitoneum (24%), pleural effusion (17%), and focal atelectasis (12%). Conclusion: POEM appears safe and effective in this meta-analysis, which included a large number of patients with low heterogeneity. Standardized training programs should be better developed to encourage safe adoption of this technique.
0.70
(4) (23) (17) (2)
0.59 0.01 0.02 0.68 1.00 0.34 1.00 1.00 1.00
0.37 0.04
Figure 1. POEM meta-analysis results
176 PerOral Endoscopic Myotomy: a Meta-Analysis Emmanuel Akintoye*, Nitin Kumar, Christopher C. Thompson Division of Gastroenterology, Brigham & Women, Boston, MA Background: Peroral endoscopic myotomy (POEM) allows endoscopic therapy of achalasia. Given the less invasive nature of this technique compared to traditional surgical approaches it is becoming more popular. Aim To evaluate the medical literature to determine the safety and efficacy of POEM. Methods: The search
AB116 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
www.giejournal.org