Low-acid Contrast Media for Preventing Post ERCP Pancreatitis

NCT07391787 | Completed

• 1 other identifier: KYLL-2025-12-013
• Study Type: observational
• Target: 3,979
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Endoscopic retrograde cholangiopancreatography; Post ERCP pancreatitis; Contrast media; pH values

Outcome Measures

Primary Outcomes (1)

• The rate of Post-ERCP pancreatitis

  According to the Cotton criteria and consensus opinions, post-ERCP pancreatitis is defined as new-onset upper abdominal pain after surgery, with amylase or lipase levels elevated to three times the upper limit of normal, and an extended hospital stay of at least 2 nights.

  Assessed up to 3 days after ERCP procedure.

Secondary Outcomes (4)

• The severity of post-ERCP pancreatitis

  Assessed up to 10 days after ERCP procedure.

• The rate of infection

  Assessed up to 3 days after ERCP procedure.

• The rate of gastrointestinal bleeding

  Assessed up to 3 days after ERCP procedure.

• Perforation

  Assessed up to 3 days after ERCP procedure.

Study Arms (3)

Ioversol

Acidic contrast media, ioversol is used for radiography during ERCP procedure.

Drug: Ioversol

Iopromide

Neutral contrast media, iopromide is used for contrast during ERCP procedure.

Drug: Iopromide

Iohexol

Alkaline contrast media, iohexol is used for contrast during ERCP procedure.

Drug: Iohexol

Interventions

Ioversol DRUG

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.

Ioversol

Iopromide DRUG

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.

Iopromide

Iohexol DRUG

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.

Iohexol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of approximately 3,881 eligible ERCP patients were included from five tertiary Grade A centers. All patients signed the informed consent form. 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.

You may qualify if:

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

You may not qualify if:

• Patients who did not use contrast media during ERCP
• Failed ERCP papillary intubation
• Patients with acute pancreatitis within 3 days before ERCP
• ERCP stent removal/replacement
• Patients who had a history of pancreaticoduodenectomy or biliary-enteric anastomosis
• Patients whose postoperative amylase/lipase levels could not be traced.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (2)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Qilu hospital, Shandong University

Jinan, Shandong, China

Location

MeSH Terms

Interventions

ioversol; iopromide; Iohexol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: February 6, 2026
• Study Start: August 1, 2025
• Primary Completion: December 25, 2025
• Study Completion: January 15, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)