TABLE 3.
Risk factors associated with the outcome of intervention on univariate analysis
| Derivation cohort | |||||
|---|---|---|---|---|---|
| Intervention status | |||||
| Risk factor | No intervention (N = 33) | Intervention (N = 25) | HR | 95% CI | p‐value |
| BMI (kg/m2) | 22.0 [19.9; 27.4] | 26.2 [24.3; 27.9] | 1.06 | 1–1.12 | 0.049 |
| Smoking status | |||||
| Never | 23 (69.7%) | 13 (52.0%) | Reference | ||
| Active | 5 (15.2%) | 4 (16.0%) | 1.37 | 0.45–4.19 | 0.59 |
| Past | 5 (15.2%) | 8 (32.0%) | 2.32 | 0.96–5.64 | 0.06 |
| Duration of stricture (Months) | 25.9 [0.00; 41.2] | 0.56 [0.00; 22.9] | 0.98 | 0.96–0.999 | 0.04 |
| Presence of nausea/vomiting | |||||
| No | 28 (84.8%) | 15 (60.0%) | Reference | ||
| Yes | 5 (15.2%) | 10 (40.0%) | 2.43 | 1.09–5.44 | 0.03 |
| Obstructive symptom index | 0.00 [0.00; 0.00] | 2.00 [0.00; 3.00] | 1.40 | 1.10–1.79 | 0.01 |
| Duration of obstructive symptoms (Months) | 19.9 [5.82; 30.1] | 10.6 [3.10; 23.8] | 0.98 | 0.95–1.02 | 0.37 |
| Biologic therapy before baseline | |||||
| No | 14 (42.4%) | 9 (36.0%) | Reference | ||
| Yes | 19 (57.6%) | 16 (64.0%) | 1.280 | 0.57–2.90 | 0.56 |
| Fecal calprotectin (mg/kg) | 244 [187; 374] | 624 [624; 624] | NA | NA | NA |
| C‐reactive protein (mg/dl) | 0.60 [0.30; 1.75] | 0.40 [0.20; 0.55] | 0.63 | 0.28–1.40 | 0.26 |
| Anastomotic stricture | |||||
| Naïve | 16 (48.5%) | 10 (40.0%) | Reference | ||
| Anastomotic | 17 (51.5%) | 15 (60.0%) | 1.30 | 0.58–2.89 | 0.53 |
| Presence of sacculations | |||||
| No | 18 (56.2%) | 13 (54.2%) | Reference | ||
| Yes | 14 (43.8%) | 11 (45.8%) | 1.05 | 0.47–2.35 | 0.91 |
| Narrowest luminal diameter within stricture (mm) | 18.5 [16.8; 21.0] | 18.0 [17.0; 22.0] | 1.04 | 0.94–1.16 | 0.42 |
| Length of stricture (cm) | 7.00 [4.35; 21.0] | 17.0 [10.0; 28.0] | 1.03 | 1.002–1.05 | 0.03 |
| Maximal diameter of proximal small bowel dilation (mm) | 35.0 [33.0; 41.0] | 36.0 [33.0; 44.0] | 1.04 | 0.995–1.08 | 0.09 |
| Perienteric fat stranding | |||||
| Absent | 26 (83.9%) | 17 (68.0%) | Reference | ||
| Present | 5 (16.1%) | 8 (32.0%) | 1.52 | 0.65–3.52 | 0.34 |
| Presence of sinus: | |||||
| Absent | 32 (97.0%) | 23 (92.0%) | Reference | ||
| Present | 1 (3.03%) | 2 (8.00%) | 2.19 | 0.51–9.31 | 0.29 |
| Maximal wall thickness of stricture | 9.00 [8.00; 10.0] | 11.0 [8.00; 12.0] | 1.12 | 0.99–1.28 | 0.08 |
| Ulceration: | |||||
| Absent | 15 (45.5%) | 10 (40.0%) | Reference | ||
| Present | 18 (54.5%) | 15 (60.0%) | 1.05 | 0.47–2.34 | 0.90 |
| Pattern of enhancement portal or enteric phase | |||||
| Stratified | 9 (27.3%) | 12 (48.0%) | Reference | ||
| Homogenous | 6 (18.2%) | 1 (4.00%) | 0.20 | 0.03–1.53 | 0.12 |
| Luminal (inner wall) only | 18 (54.5%) | 12 (48.0%) | 0.69 | 0.31–1.54 | 0.36 |
| Pattern of enhancement delayed | |||||
| Delayed GD not available | 1 (3.12%) | 2 (8.00%) | Reference | ||
| Stratified | 3 (9.38%) | 7 (28.0%) | 2.14 | 0.44–10.37 | 0.35 |
| Homogenous | 16 (50.0%) | 12 (48.0%) | 0.85 | 0.19–3.82 | 0.84 |
| Luminal (inner wall) only | 12 (37.5%) | 4 (16.0%) | 0.43 | 0.08–2.37 | 0.33 |
| Intensity of delayed enhancement | |||||
| Delayed GD not available | 1 (3.03%) | 2 (8.00%) | Reference | ||
| Greater than portal | 12 (36.4%) | 13 (52.0%) | 1.11 | 0.25–4.93 | 0.89 |
| Equal to portal | 17 (51.5%) | 10 (40.0%) | 0.72 | 0.16–3.30 | 0.67 |
| Less than portal | 3 (9.09%) | 0 (0.00%) | NA | NA | NA |
| Restricted diffusion | |||||
| DWI not available | 29 (87.9%) | 23 (92.0%) | Reference | ||
| Absent | 1 (3.03%) | 0 (0.00%) | NA | NA | NA |
| Present homogenous | 1 (3.03%) | 0 (0.00%) | NA | NA | NA |
| Present stratified | 0 (0.00%) | 1 (4.00%) | 8.59 | 1.03–71.46 | 0.047 |
| Present luminal | 2 (6.06%) | 1 (4.00%) | 0.82 | 0.11–6.09 | 0.85 |
| Intramural fat | |||||
| Absent | 5 (15.2%) | 1 (4.00%) | Reference | ||
| Present | 28 (84.8%) | 24 (96.0%) | 2.66 | 0.36–19.72 | 0.34 |
| Whiskering | |||||
| Absent | 14 (46.7%) | 8 (33.3%) | Reference | ||
| Present | 16 (53.3%) | 16 (66.7%) | 1.43 | 0.61–3.34 | 0.41 |
| Perienteric edema or fluid | |||||
| Absent | 27 (84.4%) | 20 (83.3%) | Reference | ||
| Present | 5 (15.6%) | 4 (16.7%) | 0.95 | 0.33–2.78 | 0.92 |
| Vasa recta distension | |||||
| Absent | 27 (81.8%) | 19 (76.0%) | Reference | ||
| Present | 6 (18.2%) | 6 (24.0%) | 1.23 | 0.49–3.07 | 0.67 |
| Fibrofatty proliferation | |||||
| Absent | 20 (60.6%) | 8 (32.0%) | Reference | ||
| Present | 13 (39.4%) | 17 (68.0%) | 2.36 | 1.02–5.47 | 0.046 |
| VAS increasing inflammation | 15.0 [10.0; 15.0] | 15.0 [10.0; 20.0] | 1.03 | 0.98–1.10 | 0.27 |
| VAS non‐inflammation damage | 20.0 [10.0; 30.0] | 20.0 [15.0; 30.0] | 1.02 | 0.99–1.05 | 0.26 |
| VAS global | 25.0 [20.0; 35.0] | 27.5 [20.0; 32.5] | 1.02 | 0.99–1.05 | 0.24 |
| Validation cohort | |||
|---|---|---|---|
| Intervention status | N | ||
| Risk factor | No intervention (N = 45) | Intervention (N = 41) | |
| BMI (kg/m2) | 25.8 [22.1; 27.9] | 25.9 [23.2; 27.7] | 28 |
| Smoking status | 28 | ||
| Never | 7 (58.3%) | 9 (56.2%) | |
| Active | 2 (16.7%) | 2 (12.5%) | |
| Past | 3 (25.0%) | 5 (31.2%) | |
| Duration of stricture (Months) | 0.00 [0.00; 1.41] | 16.5 [0.00; 42.7] | 28 |
| Presence of nausea/vomiting | 28 | ||
| No | 10 (83.3%) | 4 (25.0%) | |
| Yes | 2 (16.7%) | 12 (75.0%) | |
| Obstructive symptom index | 0.00 [0.00; 2.00] | 2.00 [2.00; 3.00] | 28 |
| Duration of obstructive symptoms (Months) | 5.26 [3.09; 5.65] | 14.4 [5.98; 16.8] | 18 |
| Biologic therapy before baseline | 28 | ||
| No | 4 (33.3%) | 8 (50.0%) | |
| Yes | 8 (66.7%) | 8 (50.0%) | |
| Fecal calprotectin (mg/kg) | 322 [320; 323] | 83.0 [83.0; 83.0] | 3 |
| C‐reactive protein (mg/dl) | 0.50 [0.30; 0.70] | 0.10 [0.10; 0.10] | 6 |
| Anastomotic stricture | 28 | ||
| Naïve | 5 (41.7%) | 5 (31.2%) | |
| Anastomotic | 7 (58.3%) | 11 (68.8%) | |
| Presence of sacculations | 28 | ||
| No | 9 (75.0%) | 12 (75.0%) | |
| Yes | 3 (25.0%) | 4 (25.0%) | |
| Narrowest luminal diameter within stricture (mm) | 17.0 [16.0; 20.0] | 20.0 [18.0; 21.0] | 27 |
| Length of stricture (cm) | 8.20 [4.75; 24.2] | 9.75 [4.90; 16.5] | 28 |
| Maximal diameter of proximal small bowel dilation (mm) | 35.0 [32.0; 36.5] | 34.5 [32.5; 45.0] | 28 |
| Perienteric fat stranding | 28 | ||
| Absent | 10 (83.3%) | 13 (81.2%) | |
| Present | 2 (16.7%) | 3 (18.8%) | |
| Presence of sinus | 28 | ||
| Absent | 10 (83.3%) | 15 (93.8%) | |
| Present | 2 (16.7%) | 1 (6.25%) | |
| Maximal wall thickness of stricture | 10.0 [7.00; 11.2] | 9.50 [8.00; 11.0] | 28 |
| Ulceration | 28 | ||
| Absent | 5 (41.7%) | 8 (50.0%) | |
| Present | 7 (58.3%) | 8 (50.0%) | |
| Pattern of enhancement portal or enteric phase | 28 | ||
| Stratified | 4 (33.3%) | 6 (37.5%) | |
| Homogenous | 4 (33.3%) | 3 (18.8%) | |
| Luminal (inner wall) only | 4 (33.3%) | 7 (43.8%) | |
| Pattern of enhancement delayed | 28 | ||
| Delayed GD not available | 1 (8.33%) | 0 (0.00%) | |
| Stratified | 1 (8.33%) | 6 (37.5%) | |
| Homogenous | 8 (66.7%) | 10 (62.5%) | |
| Luminal (inner wall) only | 2 (16.7%) | 0 (0.00%) | |
| Intensity of delayed enhancement | 28 | ||
| Delayed GD not available | 1 (8.33%) | 0 (0.00%) | |
| Greater than portal | 6 (50.0%) | 6 (37.5%) | |
| Equal to portal | 4 (33.3%) | 10 (62.5%) | |
| Less than portal | 1 (8.33%) | 0 (0.00%) | |
| Restricted diffusion | 28 | ||
| DWI not available | 2 (16.7%) | 0 (0.00%) | |
| Absent | 2 (16.7%) | 4 (25.0%) | |
| Present homogenous | 3 (25.0%) | 4 (25.0%) | |
| Present stratified | 2 (16.7%) | 3 (18.8%) | |
| Present luminal | 3 (25.0%) | 5 (31.2%) | |
| Intramural fat | 28 | ||
| Absent | 0 (0.00%) | 2 (12.5%) | |
| Present | 12 (100%) | 14 (87.5%) | |
| Whiskering | 27 | ||
| Absent | 6 (54.5%) | 8 (50.0%) | |
| Present | 5 (45.5%) | 8 (50.0%) | |
| Perienteric edema or fluid | 27 | ||
| Absent | 11 (91.7%) | 13 (86.7%) | |
| Present | 1 (8.33%) | 2 (13.3%) | |
| Vasa recta distension: | 28 | ||
| Absent | 10 (83.3%) | 14 (87.5%) | |
| Present | 2 (16.7%) | 2 (12.5%) | |
| Fibrofatty proliferation | 28 | ||
| Absent | 6 (50.0%) | 7 (43.8%) | |
| Present | 6 (50.0%) | 9 (56.2%) | |
| VAS increasing inflammation | 15.0 [10.0; 21.2] | 17.5 [10.0; 25.0] | 28 |
| VAS non‐inflammation damage | 20.0 [15.0; 25.0] | 27.5 [15.0; 35.0] | 28 |
| VAS global | 25.0 [23.8; 36.2] | 32.5 [23.8; 40.0] | 28 |
Note: Statistics presented as Median [P25, P75] and N (column %). Bold values denote statistical significance at the p 〈 0.05 level.
Abbreviations: BMI, body mass index; CI, confidence interval; DWI, diffusion‐weighted imaging; EBD, endoscopic balloon dilation; GD, gadolinium; HR, hazard ratio; NA, not applicable; VAS, visual analog scale.