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©2014 Baishideng Publishing Group Inc.
World J Gastroenterol. Dec 28, 2014; 20(48): 18199-18206
Published online Dec 28, 2014. doi: 10.3748/wjg.v20.i48.18199
Published online Dec 28, 2014. doi: 10.3748/wjg.v20.i48.18199
Table 1 Baseline characteristics
Endoscopic balloon dilatation | Biodegradable Stent | Mean difference | P value1 | |||||||
mean ± SD | Min | Max | n | mean ± SD | Min | Max | n | |||
Age (yr) | 63.8 ± 9.1 | 54 | 74 | 6 | 62.7 ± 12.5 | 40 | 78 | 9 | -1.1 | 1.000 |
Age at diagnosis (yr) | 61.9 ± 10.5 | 49 | 74 | 6 | 59.6 ± 13.9 | 36 | 77 | 9 | -2.3 | 0.955 |
Gender male:female | [5:1] | [8:1] | 1.000 | |||||||
Weight (kg) | 61.0 ± 10.0 | 47 | 71 | 6 | 71.7 ± 29.5 | 45 | 141 | 9 | 10.7 | 0.864 |
Height (cm) | 168 ± 14 | 143 | 181 | 6 | 170 ± 10 | 156 | 188 | 9 | 2.0 | 1.000 |
Smoking (never:previously:currently) | (1:2:3) | (4:2:3) | 0.660 | |||||||
Time since quitting smoking (yr) | 4.3 ± 5.7 | 0.3 | 8.3 | 2 | 1.8 ± 1.5 | 0.7 | 2.8 | 2 | -2.5 | 1.000 |
n cigarettes/d (if current) | 18.3 ± 2.9 | 15 | 20 | 3 | 18.3 ± 2.9 | 15 | 20 | 3 | 0.0 | 1.000 |
Current drinker (no:yes) | (3:3) | (4:5) | 1.000 | |||||||
Alcohol units/w (if current) | 22.3 ± 17.2 | 10 | 42 | 3 | 15.8 ± 11.0 | 1 | 29 | 5 | -6.5 | 0.786 |
Number of dilatations (ever) | 3.2 ± 2.3 | 1 | 6 | 6 | 6.2 ± 5.1 | 1 | 16 | 9 | 3.0 | 0.224 |
Number of dilatations (in last 12 m) | 1.2 ± 0.8 | 0 | 2 | 6 | 1.9 ± 1.8 | 0 | 5 | 9 | 0.7 | 0.607 |
Stricture length (cm)2 | 4.0 ± 1.9 | 2 | 6 | 5 | 3.5 ± 1.3 | 2 | 5 | 8 | -0.5 | 0.524 |
Luminal diameter (mm)2 | 12.3 ± 4.9 | 9 | 18 | 3 | 23.2 ± 31.8 | 6 | 80 | 5 | 10.9 | 1.000 |
Extent of stricture (from)2 | 31.0 ± 3.7 | 25 | 36 | 6 | 34.6 ± 2.5 | 30 | 38 | 8 | 3.6 | 0.081 |
Extent of stricture (to)2 | 35.8 ± 2.9 | 32 | 40 | 5 | 38.0 ± 1.9 | 34 | 40 | 8 | 2.2 | 0.171 |
Dysphagia score (baseline) | 1.83 ± 0.98 | 1 | 3 | 6 | 2.00 ± 1.22 | 0 | 4 | 9 | 0.17 | 0.776 |
EQ5D score (baseline) | 0.69 ± 0.31 | 0.26 | 1 | 6 | 0.69 ± 0.24 | 0.36 | 1 | 9 | 0.00 | 0.955 |
EQVAS score (baseline) | 73 ± 21 | 35 | 95 | 6 | 57 ± 22 | 30 | 95 | 9 | -16 | 0.145 |
Intervention balloon dilatation (mm) | 14.5 ± 1.2 | 12 | 15 | 6 | ||||||
Intervention stent length (mm) | 96.1 ± 31.5 | 60 | 135 | 9 | ||||||
Intervention fluoroscopy (no:yes) | (4:2) | (0:9) | 0.011 |
Table 2 Baseline comorbidities n (%)
Endoscopic balloon dilatation (n = 6) | Biodegradable stent (n = 9) | P value1 | |
Alcohol dependence | 3 (50) | 5 (56) | 1.000 |
Alcohol overdose | 0 (0) | 1 (11) | 1.000 |
Appendicitis | 1 (17) | 1 (11) | 1.000 |
Barrett's oesophagus | 0 (0) | 1 (11) | 1.000 |
Biliary colic | 0 (0) | 1 (11) | 1.000 |
Diarrhoea | 0 (0) | 1 (11) | 1.000 |
Diverticular disease | 2 (33) | 1 (11) | 0.525 |
Duodenitis | 0 (0) | 1 (11) | 1.000 |
Reflux disease/oesophagitis | 4 (67) | 3 (33) | 0.315 |
Haematemesis | 1 (17) | 0 (0) | 0.400 |
Helicobacter pylori | 1 (17) | 0 (0) | 0.400 |
Hiatus hernia | 2 (33) | 3 (33) | 1.000 |
Inguinal hernia | 0 (0) | 1 (11) | 1.000 |
Ischaemic sigmoid colon stricture | 0 (0) | 1 (11) | 1.000 |
Oesophageal perforation | 0 (0) | 1 (11) | 1.000 |
Perforated duodenal ulcer | 1 (17) | 0 (0) | 0.400 |
Reversal of ileostomy | 0 (0) | 1 (11) | 1.000 |
Wernicke's Encephalopathy | 0 (0) | 1 (11) | 1.000 |
Table 3 Outcomes
Endoscopic balloon dilatation | Biodegradable stent | Mean difference | 95%CI | P value1 | P value2 | |||||||
mean ± SD | Min | Max | n | mean ± SD | Min | Max | n | |||||
Primary endpoint | ||||||||||||
Dysphagia Score (Average 3 and 6 m) | 0.00 ± 0.00 | 0.00 | 0.00 | 5 | 1.17 ± 0.90 | 0.00 | 3.00 | 9 | 1.17 | 0.63-1.78 | 0.029 | 0.004 |
Secondary endpoints | ||||||||||||
Dysphagia Score (AUC 0-6 m) | 0.25 ± 0.13 | 0.13 | 0.38 | 5 | 0.71 ± 0.46 | 0.25 | 1.50 | 9 | 0.46 | 0.16-0.78 | 0.045 | 0.042 |
Dysphagia Score (Average 3, 6 and 12 m) | 0.00 ± 0.00 | 0.00 | 0.00 | 4 | 1.21 ± 1.08 | 0.00 | 3.33 | 8 | 1.21 | 0.56-2.00 | 0.052 | 0.016 |
Dysphagia Score (AUC 0-12 m) | 0.22 ± 0.12 | 0.13 | 0.38 | 4 | 1.28 ± 1.01 | 0.25 | 3.25 | 8 | 1.06 | 0.43-1.81 | 0.066 | 0.008 |
QALY (EQ5D 0-6 m) | 0.34 ± 0.16 | 0.18 | 0.50 | 5 | 0.35 ± 0.10 | 0.22 | 0.48 | 9 | 0.00 | -0.15-0.15 | 0.995 | 1.000 |
QALY (EQ5D 0-12 m) | 0.64 ± 0.42 | 0.14 | 1.00 | 4 | 0.66 ± 0.23 | 0.38 | 0.98 | 7 | 0.01 | -0.38-0.47 | 0.949 | 0.927 |
QALY (EQVAS 0-6 m) | 0.36 ± 0.09 | 0.24 | 0.46 | 5 | 0.32 ± 0.09 | 0.22 | 0.45 | 9 | -0.04 | -0.14-0.05 | 0.385 | 0.364 |
QALY (EQVAS 0-12 m) | 0.73 ± 0.20 | 0.49 | 0.92 | 4 | 0.67 ± 0.21 | 0.42 | 0.94 | 7 | -0.07 | -0.29-0.18 | 0.602 | 0.648 |
Number of additional procedures (0-6 m) | 0.80 ± 1.10 | 0.00 | 2.00 | 5 | 3.22 ± 2.91 | 0.00 | 8.00 | 9 | 2.42 | 0.127 | ||
Number of endoscopic procedures (0-6 m) | 0.00 ± 0.00 | 0.00 | 0.00 | 5 | 0.33 ± 0.71 | 0.00 | 2.00 | 9 | 0.33 | 0.505 | ||
Number of balloon procedures (0-6 m) | 0.40 ± 0.55 | 0.00 | 1.00 | 5 | 1.22 ± 1.39 | 0.00 | 4.00 | 9 | 0.82 | 0.275 | ||
Number of endoscopies (0-6 m) | 0.40 ± 0.55 | 0.00 | 1.00 | 5 | 1.67 ± 1.50 | 0.00 | 4.00 | 9 | 1.27 | 0.107 | ||
Number of additional procedures (0-12 m) | 1.20 ± 0.84 | 0.00 | 2.00 | 5 | 4.13 ± 3.87 | 0.00 | 10.0 | 8 | 2.93 | 0.165 | ||
Number of endoscopic procedures (0-12 m) | 0.00 ± 0.00 | 0.00 | 0.00 | 5 | 0.63 ± 1.06 | 0.00 | 3.00 | 8 | 0.63 | 0.417 | ||
Number of balloon procedures (0-12 m) | 0.40 ± 0.55 | 0.00 | 1.00 | 5 | 1.38 ± 1.77 | 0.00 | 5.00 | 8 | 0.98 | 0.385 | ||
Number of endoscopies (0-12 m) | 0.80 ± 0.45 | 0.00 | 1.00 | 5 | 2.13 ± 1.89 | 0.00 | 5.00 | 8 | 1.33 | 0.203 |
Table 4 Sensitivity analyses
Mean difference | 95%CI | P value1 | P value2 | |
Repeated measures ANOVA | ||||
Dysphagia score (3, 6 m) | 1.17 | (0.21-2.13) | 0.022 | |
Dysphagia score (3, 6, 12 m) | 1.10 | (-0.11-2.31) | 0.070 | |
Repeated measures ANOVA (imputed) | ||||
Dysphagia score (3, 6 m) | 1.13 | (-0.05-2.32) | 0.058 | |
Dysphagia score (3, 6, 12 m) | 1.01 | (-0.30-2.32) | 0.113 | |
Dysphagia score (imputed) | ||||
Dysphagia score (Average 3 and 6 m) | 0.94 | (0.18-1.70) | 0.015 | 0.021 |
Dysphagia score (Average 3, 6 and 12 m) | 0.93 | (0.06-1.79) | 0.036 | 0.025 |
Dysphagia score (AUC 0-6 m) | 0.38 | (0.03-0.73) | 0.032 | 0.075 |
Dysphagia score (AUC 0-12 m) | 0.83 | (0.07-1.58) | 0.033 | 0.024 |
Table 5 Number of patients with adverse events
Adverse event1 | Endoscopic balloon dilatation (n = 9) | Biodegradable stent (n = 6) | ||
Unrelated | Related | Unrelated | Related | |
Abdominal pain | 2 | 1 (1) | ||
Acute exacerbation of chronic bronchitis | 1 | |||
Acute pancreatitis | 1 | |||
Alcohol withdrawal syndrome | 1 (1) | |||
Atrial fibrillation | 1 | |||
Chronic obstructive pulmonary disease | 1 | |||
Constipation | 1 | |||
Cough | 1 | |||
Diverticulosis | 1 | |||
Dry mouth | 1 | |||
Dysphagia | 1 | 1 | 6 (1) | 1 (1) |
Dyspnoea | 1 | |||
Eye infection - Left eye | 1 | |||
Foul taste in mouth | 1 | |||
Fractured rib | 1 (1) | |||
Gastro-oesophageal reflux | 1 | |||
Haematemesis | 2 | 1 | ||
Hiccups | 1 | |||
Hyperglycemia | 1 (1) | 1 | ||
Hypertension | 1 | |||
Hypotension | 1 (1) | |||
Insomnia | 1 | |||
Oesophageal candidiasis | 1 | |||
Oesophageal spasm | 1 | |||
Pain | 2 (1) | 1 | ||
Positive Faecal occult blood test | 1 | |||
Pruritus - Lower legs (right and left) | 1 (1) | |||
Retrosternal pain | 1 | |||
Vitamin B deficiency | 1 | |||
Vomiting | 1 |
Table 6 Number of patients receiving concomitant medication
Endoscopic balloon dilatation (n = 9) | Biodegradable stent (n = 6) | |
Bowel management | ||
Loperamide | 1 | 0 |
Constipation | ||
Laxative | 1 | 2 |
Haematemesis | ||
Metoclopramide | 0 | 1 |
Heartburn | ||
Alginate | 0 | 1 |
Nausea/vomiting | 1 | 4 |
Cyclizine | 0 | 3 |
Domperidone | 0 | 2 |
Metoclopramide | 1 | 4 |
Nutritional deficit | ||
Nutritional Supplement | 1 | 4 |
Oesophageal candidiasis | ||
Antifungal | 0 | 1 |
Symptoms of BOS/reflux disease | 6 | 9 |
Proton pump inhibitor | 5 | 9 |
H2-receptor antagonist | 1 | 2 |
Sucralfate | 0 | 1 |
- Citation: Dhar A, Close H, Viswanath YK, Rees CJ, Hancock HC, Dwarakanath AD, Maier RH, Wilson D, Mason JM. Biodegradable stent or balloon dilatation for benign oesophageal stricture: Pilot randomised controlled trial. World J Gastroenterol 2014; 20(48): 18199-18206
- URL: https://www.wjgnet.com/1007-9327/full/v20/i48/18199.htm
- DOI: https://dx.doi.org/10.3748/wjg.v20.i48.18199