Low-acid Contrast Media for Preventing Post ERCP Pancreatitis

Summary

Title： Low-acid contrast media for preventing post ERCP pancreatitis: a multicenter, retrospective, cohort study (LAMP-R) .

Objective:

Main objective: This study aims to determine whether low-acid contrast media can reduce the incidence of post-ERCP pancreatitis.

Secondary objective: To investigate the severity of post-ERCP pancreatitis, the incidence rate of other complications, and the risk factors associated with different pH values of contrast media.

Research Design：Multicenter, retrospective cohort study.

Research participants:

Inclusion criteria: Patients aged 18 to 90 years who underwent ERCP diagnostic and therapeutic procedures were included consecutively.

Exclusion criteria: Patients who did not use contrast medium during ERCP, failed ERCP papillary intubation, developed acute pancreatitis within 3 days before surgery, ERCP stent removal/replacement, had a history of pancreaticoduodenectomy or biliary-enteric anastomosis, and whose postoperative amylase/lipase levels could not be traced were excluded.

Outcomes:

1\. The rate of post-ERCP pancreatitis and severity of PEP 2. The rate of infection 3. The rate of gastrointestinal bleeding 4. The rate of perforation.

Sample size calculation:

A total of approximately 3,881 eligible ERCP patients were included from five tertiary Grade A centers. Specifically, 2,305 patients were from Qilu Hospital of Shandong University, 463 from Linyi People's Hospital, 121 from Qilu Third Hospital of Shandong University, 106 from Dezhou Hospital of Qilu Hospital of Shandong University, and 886 from Shengli Oilfield Central Hospital.

Statistical analysis SPSS 27 is used for statistics and analysis, including descriptive analysis, single-factor and multi-factor logistic regression analysis, analysis of variance, t-test, propensity score matching (PSM), etc. Categorical data are presented as counts and proportions, while continuous data are presented as mean ± standard deviation, depending on the distribution. Categorical data are analyzed using χ2 and Fisher's exact test, and continuous data are analyzed using Student's t-test or Mann-Whitney U test. Primary and secondary outcomes are presented as relative risks (RRs) with 95% confidence intervals (CIs).

Conditions

• Post-ERCP Acute Pancreatitis

Interventions

DRUG

Ioversol

Ioversol was used for intervention in the ERCP procedure, while iopromide was used for controlled. ERCP was performed using endoscopes from different suppliers, and the guidewire assisted method were used for the papillary intubation.

DRUG

Iopromide

Iopromide was used for ERCP procedure as controlled group. ERCP was performed using endoscopes from different suppliers, and the guidewire assisted method were used for the papillary intubation.

DRUG

Iohexol

Iohexol was used for intervention in the ERCP procedure, while iopromide was used for controlled. ERCP was performed using endoscopes from different suppliers, and the guidewire assisted method were used for the papillary intubation.

Sponsors & Collaborators

• Shandong University

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-01

Primary Completion

2025-12-25

Completion

2026-01-15

Countries

• China

Study Locations