A new preprocedural predictive risk model for post-endoscopic retrograde cholangiopancreatography pancreatitis: The SuPER model

  1. Mitsuru Sugimoto  Is a corresponding author
  2. Tadayuki Takagi
  3. Tomohiro Suzuki
  4. Hiroshi Shimizu
  5. Goro Shibukawa
  6. Yuki Nakajima
  7. Yutaro Takeda
  8. Yuki Noguchi
  9. Reiko Kobayashi
  10. Hidemichi Imamura
  11. Hiroyuki Asama
  12. Naoki Konno
  13. Yuichi Waragai
  14. Hidenobu Akatsuka
  15. Rei Suzuki
  16. Takuto Hikichi
  17. Hiromasa Ohira
  1. Department of Gastroenterology, Fukushima Medical University, School of Medicine, Japan
  2. Department of Gastroenterology, Fukushima Rosai Hospital, Japan
  3. Department of Gastroenterology, Aizu Medical Center, Fukushima Medical University, Japan
  4. Department of Gastroenterology, Ohta Nishinouchi Hospital, Japan
  5. Department of Gastroenterology, Fukushima Redcross Hospital, Japan
  6. Department of Gastroenterology, Soma General Hospital, Japan
  7. Department of Gastroenterology, Saiseikai Fukushima General Hospital, Japan
  8. Department of Endoscopy, Fukushima Medical University Hospital, Japan
2 figures, 4 tables and 4 additional files

Figures

Flowchart of the inclusion criteria.

ERCP, endoscopic retrograde cholangiopancreatography.

Example of the preprocedural PEP risk checklist.

ERCP, endoscopic retrograde cholangiopancreatography; IPMN, intraductal papillary mucinous neoplasm; PEP, post-ERCP pancreatitis.

Tables

Table 1
Comparison of patient characteristics and ERCP outcomes between the development and validation cohorts.
Development cohort(n=1037)Validation cohort(n=1037)p-Value
Patient factors
Age, years, mean ± SD73.8 ± 12.775.1 ± 12.50.02
Sex, n, male/female642/395629/4080.59
History of pancreatitis, n (%)73 (7.0)45 (4.4)0.01
History of PEP, n (%)26 (2.5)24 (2.3)0.89
History of gastrectomy, n (%)82 (7.9)88 (8.5)0.69
 Billroth-I reconstruction, n2425
 Billroth-II reconstruction, n2325
 Roux-en-Y reconstruction, n3336
 Double tract, n11
 Gastric tube reconstruction, n11
Pancreatic cancer, n (%)145 (14.0)174 (16.8)0.09
IPMN, n (%)17 (1.6)8 (0.8)0.11
Native papilla of Vater, n (%)535 (51.6)494 (47.7)0.08
Total bilirubin, mg/dl, mean ± SD *3.5 ± 5.33.6 ± 5.00.45
Diameter of the MPD, mm, mean ± SD 2.84 ± 2.633.1 ± 2.90.10
Pancreatic calcification, n (%) 107 (10.6)87 (8.7)0.15
Periampullary diverticulum, n (%)207 (20.0)224 (21.6)0.39
Pre-ERCP prophylaxis
Protease inhibitors, n (%)709 (68.4)703 (67.8)0.81
Intravenous hydration, n (%)22 (2.1)14 (1.4)0.24
NSAID suppository, n (%)53 (5.1)45 (4.3)0.47
Factors related to the planned procedure
EST, n (%)449 (43.3)434 (41.9)0.53
EPBD, n (%)31 (3.0)40 (3.9)0.33
EPLBD, n (%)56 (5.4)55 (5.3)1.0
Biliary stone removal, n (%)327 (31.5)342 (33.0)0.51
Ampullectomy, n (%)5 (0.5)5 (0.5)1.0
Biliary stent, n (%)594 (57.3)611 (58/9)0.48
 Plastic stent, n (%)445 (42.9)436 (42.0)0.72
 SEMS, n (%)119 (11.5)122 (11.8)0.89
 CSEMS, n (%)36 (3.5)44 (4.2)0.43
Biliary stent above the papilla, n (%)45 (4.3)47 (4.5)0.92
Procedures on the pancreatic duct, n (%)285 (27.5)237 (22.9)0.017
PEP occurrence, n (%)70 (6.8)64 (6.2)0.66
 Mild, n6053
 Moderate, n87
 Severe, n24
  1. ERCP, endoscopic retrograde cholangiopancreatography; PEP, post-ERCP pancreatitis; IPMN, intraductal papillary mucinous neoplasm; MPD, main pancreatic duct; EST, endoscopic sphincterotomy; EPBD, endoscopic papillary balloon dilation; SEMS, self-expandable metallic stent; CSEMS, covered SEMS.

  2. *

    Data were available for 2042 patients.

  3. Data were available for 1671 patients.

  4. Data were available for 2017 patients.

Table 2
Logistic regression analysis of predictive factors for PEP in the development cohort.
Univariate analysisMultivariate analysis
OR95% CIp- ValueOR95% CIp-ValueRegression coefficientPoints
Age <50 years2.420.99–6.00.0531.760.67–4.630.250.56-
Female1.911.17–3.10<0.011.721.03–2.890.0390.551
History of pancreatitis1.260.53–3.00.61
History of PEP1.840.54–6.280.33
History of gastrectomy0.890.35–2.270.81
Pancreatic cancer1.030.51–2.060.94
IPMN8.152.92–22.7<0.013.040.97–9.520.0561.112
Native papilla of Vater4.492.42–8.30<0.012.721.30–5.71<0.011.02
Total bilirubin ≤1.2 mg/dl *1.130.69–1.840.62
Diameter of the MPD >3 mm1.310.76–2.250.33
Pancreatic calcification0.360.11–1.170.0890.320.10–1.10.072–1.13-2
Periampullary diverticulum0.650.33–1.300.22
Protease inhibitors0.720.44–1.190.20
Intravenous hydration1.390.32–6.080.66
NSAID suppository before ERCP1.470.57–3.830.43
EST1.711.05–2.790.030.830.45–1.520.54–0.19-
EPBD<0.010–infinity0.98
EPLBD0.240.03–1.760.16
Biliary stone removal0.680.39–1.190.18
Ampullectomy3.490.39–31.60.27
Biliary stent0.930.57–1.520.78
 Plastic stent0.720.44–1.200.21
 SEMS1.660.87–3.200.13
 CSEMS0.810.19–3.430.77
Biliary stent above the papilla0.300.04–2.240.24
Procedures on the pancreatic duct4.772.89–7.89<0.013.491.99–6.12<0.011.252
  1. PEP, post–endoscopic retrograde cholangiopancreatography pancreatitis; IPMN, intraductal papillary mucinous neoplasm; MPD, main pancreatic duct; EST, endoscopic sphincterotomy; EPBD, endoscopic papillary balloon dilation; EPLBD, endoscopic papillary large balloon dilation; SEMS, self-expandable metallic stent; CSEMS, covered SEMS.

  2. *

    Data were available for 1024 patients in the development cohort.

  3. Data were available for 985 patients in the development cohort.

  4. Data were available for 1012 patients in the development cohort.

Table 3
Patient distribution in terms of risk score and classification.
Risk scoreDevelopment cohort (n=1012) *Validation cohort (n=1005)
PEP occurrence, NPEP rate (95% CI) (%)p-Value PEP occurrence, NPEP rate (95% CI) (%)p-Value
-20/290 (0–11.9)<0.010/330 (0–10.6)<0.01
-10/90 (0–33.6)0/50 (0–52.2)
00/2890 (0–1.3)8/2932.7 (1.2–5.3)
16/1404.3 (1.6–9.1)5/1603.1 (1.0–7.1)
28/2024.0 (1.7–7.7)14/1957.2 (4.0–11.8)
313/1508.7 (4.7–14.4)8/1585.1 (2.2–9.7)
418/9718.6 (11.4–27.7)14/8416.7 (9.4–26.4)
517/8320.5 (12.4–30.8)14/7119.7 (11.2–30.9)
63/933.3 (7.5–70.1)0/30 (0–70.8)
71/425.0 (0.6–80.6)1/333.3 (0.8–90.6)
Risk classificationRisk scorePEP occurrence, NPEP rate (95% CI) (%)p-Value PEP occurrence, NPEP rate (95% CI) (%)p-Value
Low≤00/3270 (0–1.1)<0.018/3312.4 (1.0–4.7)<0.01
Moderate1–327/4925.5 (3.6–7.9)27/5135.3 (3.5–7.6)
High4–739/19320.2 (14.8–26.6)29/16118.0 (12.4–24.8)
  1. PEP, post–endoscopic retrograde cholangiopancreatography pancreatitis.

  2. *

    There were missing data for 25 patients.

  3. Data for 32 patients were missing.

  4. The correlations between the risk score or classification and PEP occurrence were evaluated via the Cochran–Armitage test.

Table 4
Goodness of fit of the risk score model.
Development cohortValidation cohort
C statistic (95% CI)0.77 (0.72–0.82)0.71 (0.64–0.78)
Hosmer‒Lemeshow test, p value0.590.40

Additional files

Supplementary file 1

Risk classification and unpredictable intraprocedural risk factors for PEP (multivariate logistic regression).

PEP, post-endoscopic retrograde cholangiopancreatography pancreatitis. a Patients with missing data for variables selected in the risk score model were removed.

https://cdn.elifesciences.org/articles/101604/elife-101604-supp1-v1.docx
Supplementary file 2

Risk of PEP following implantation of pancreatic stents (logistic regression).

PEP, post-endoscopic retrograde cholangiopancreatography pancreatitis.

https://cdn.elifesciences.org/articles/101604/elife-101604-supp2-v1.docx
MDAR checklist
https://cdn.elifesciences.org/articles/101604/elife-101604-mdarchecklist1-v1.pdf
Source data 1

The dataset was original raw data without personal information.

The data was anonymized and deidentified.

https://cdn.elifesciences.org/articles/101604/elife-101604-data1-v1.xlsx

Download links

A two-part list of links to download the article, or parts of the article, in various formats.

Downloads (link to download the article as PDF)

Open citations (links to open the citations from this article in various online reference manager services)

Cite this article (links to download the citations from this article in formats compatible with various reference manager tools)

  1. Mitsuru Sugimoto
  2. Tadayuki Takagi
  3. Tomohiro Suzuki
  4. Hiroshi Shimizu
  5. Goro Shibukawa
  6. Yuki Nakajima
  7. Yutaro Takeda
  8. Yuki Noguchi
  9. Reiko Kobayashi
  10. Hidemichi Imamura
  11. Hiroyuki Asama
  12. Naoki Konno
  13. Yuichi Waragai
  14. Hidenobu Akatsuka
  15. Rei Suzuki
  16. Takuto Hikichi
  17. Hiromasa Ohira
(2025)
A new preprocedural predictive risk model for post-endoscopic retrograde cholangiopancreatography pancreatitis: The SuPER model
eLife 13:RP101604.
https://doi.org/10.7554/eLife.101604.3