Table 1.
Biochemical and Psychosocial Characteristics
| Patient characteristic | RESPOnD SOD only | RESPOnD iRAP | RESPOnD total | EPISOD | RESPOnD vs EPISOD, P value | RESPOnD SOD only vs EPISOD, P value |
|---|---|---|---|---|---|---|
|
| ||||||
| Bile duct diameter, mm, median (IQR) | 10 (7–14) | 7 (5–10) | 9 (6–12) | 7 (5–8) | ||
| Bile duct diameter ≥10 mm, n (%) | 34 (45.9) | 8 (21.1) | 42 (37.5) | 5 (2.4) | ||
| Pancreatic duct diameter, mm, median (IQR) | 2.7 (2–4) | 2 (1.5–4) | 2.3 (2–4) | N/A | ||
| Biliary laboratory results | ||||||
| AST range, n (%) | ||||||
| Normal | 28 (35.4) | 25 (55.6) | 53 (42.7) | 195 (97) | ||
| 1–2× ULN | 12 (15.2) | 5 (11.1) | 17 (13.7) | 6 (3) | ||
| >2× ULN | 39 (49.4) | 15 (33.3) | 54 (43.5) | 0 (0) | ||
| ALT range, n (%) | ||||||
| Normal | 24 (39.3) | 27 (69.2) | 51 (51) | 193 (95.1) | ||
| 1–2× ULN | 14 (23) | 7 (17.9) | 21 (21) | 10 (4.9) | ||
| >2× ULN | 23 (37.7) | 5 (12.8) | 28 (28) | 0 (0) | ||
| AP range, n (%) | ||||||
| Normal | 39 (49.4) | 29 (64.4) | 68 (54.8) | 197 (98) | ||
| 1–2× ULN | 31 (39.2) | 12 (26.7) | 43 (34.7) | 4 (2) | ||
| >2× ULN | 9 (11.4) | 4 (8.9) | 13 (10.5) | 0 (0) | ||
| AST, ALT, or AP >2× ULN, n (%) | 44 (55.7) | 16 (35.6) | 60 (48.4) | 0 (0) | ||
| Pancreatic laboratory results | ||||||
| Lipase range, n (%) | ||||||
| Normal | 49 (81.7) | 11 (26.8) | 60 (59.4) | 192 (95) | ||
| 1–3× ULN | 4 (6.7) | 9 (22) | 13 (12.9) | 10 (5) | ||
| >3× ULN | 7 (11.7) | 21 (51.2) | 28 (27.7) | 0 (0) | ||
| Amylase range, n (%) | ||||||
| Normal | 17 (85) | 10 (55.6) | 27 (71.1) | 199 (98.5) | ||
| 1–3× ULN | 0 (0) | 3 (16.7) | 3 (7.9) | 3 (1.5) | ||
| >3× ULN | 3 (15) | 5 (27.8) | 8 (21.1) | 0 (0) | ||
| Lipase or amylase >3× ULN, n (%) | 9 (14.8) | 22 (52.4) | 31 (30.1) | 0 (0) | ||
| Pain characteristic | ||||||
| Days of pain episodes in past 90 days, median (IQR) | 61.5 (10–90) | 18 (6–45) | 30 (10–90) | 85 (48–90) | <.0001 | .1893 |
| Pain intensity (0–10) in past 90 days, median (IQR) | 7 (6–9) | 7.5 (6–10) | 7 (6–9) | 7 (5–8) | .4101 | 1.000 |
| Pain burden (frequency × intensity product) in past 90 days, median (IQR) | 360 (72–630) | 150 (56–320) | 210 (70–540) | 450 (300–630) | <.0001 | .2584 |
| Psychosocial characteristic | ||||||
| High likelihood of depression,a n (%) | 8 (12.3) | 3 (7.9) | 11 (10.7) | 11 (5.1) | 1.000 | 1.000 |
| High likelihood of anxietyb n (%) | 16 (24.6) | 6 (15.8) | 22 (21.4) | 17 (7.9) | .0185 | .0075 |
| Low physical health,c n (%) | 27 (42.2) | 10 (26.3) | 37 (36.3) | 118 (55.1) | .0479 | 1.000 |
| Low mental healthd n (%) | 27 (42.2) | 8 (21.1) | 35 (34.3) | 41 (19.2) | .0898 | .0048 |
NOTE. All P values were adjusted using Bonferroni correction for multiple comparisons. Comparative statistics are not included for duct and oratory characteristics given differences in study enrollment criteria.
AP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BSI, Brief Symptom Inventory; EPISOD, Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction; HADS, Hospital Anxiety and Depression Scale; IQR, interquartile range; iRAP, idiopathic recurrent acute pancreatitis; PROMIS-29, Patient-Reported Outcomes Measurement Information System 29; RESPOnD, Results of Endoscopic retrograde cholangiopancreatography for SPhincter of Oddi Disorders; SOD, sphincter of Oddi dysfunction; ULN, upper limit of normal.
High likelihood of depression was defined by a BSI-18 T score ≥65 in EPISOD and Beck Depression Inventory II >18 in EPISOD.
High likelihood of anxiety was defined by a HADS Anxiety score ≥11 in EPISOD and a BSI-18 Anxiety T score ≥65 in RESPOnD.
Low physical health was defined as a Short Form-36 Physical Component T Score ≤40 in EPISOD and a PROMIS-29 Physical Health Summary T score ≤40 in RESPOnD.
Low mental health was defined as a Short Form-36 Mental Component T Score ≤40 in EPISOD and a PROMIS-29 Mental Health Summary T score ≤40 in RESPOnD.