NCT06277414

Brief Summary

To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

7 years

First QC Date

February 19, 2024

Last Update Submit

February 19, 2024

Conditions

Endoscopic Retrograde Cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Pancreatitis

    Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after ERCP.

    1 month

Secondary Outcomes (4)

  • Number of Acute PEC(post-ERCP-cholecystitis )

    1 month

  • Number of Participants with Cholangitis

    1 month

  • Number of Participants with Perforation

    1 month

  • Number of Participants with bile duct stents

    1 month

Study Arms (1)

ERCP

The postoperative laboratory test results, imaging results and symptoms were collected

Other: collection of laboratory test results, imaging results and symptoms

Interventions

collection of laboratory test results, imaging results and symptomsOTHER

collection of laboratory test results, imaging results and symptoms

ERCP

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Routine ERCP patients

You may qualify if:

  • Routine ERCP patients

You may not qualify if:

  • Unwillingness or inability to consent for the study
  • Pregnant women or breastfeeding
  • current acute pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The blood will be collected and detected

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 26, 2024

Study Start

January 1, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

CN(1)