NCT04619511

Brief Summary

The study aimed to identify risk factors for post-ERCP pancreatitis(PEP) after ESWL, and the relationship between the occurrence of post-ESWL pancreatitis and PEP.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
714

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Status
completed

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

October 31, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

2.7 years

First QC Date

November 3, 2020

Last Update Submit

November 3, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • post endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis

    The main outcome analyzed was the development of post-procedural pancreatitis, which was defined as clinical pancreatitis, meeting two of three the following criteria in accordance with the Revised Atlanta International consensus including pain consistent with AP; amylase or lipase more than 3 times the upper normal limit; characteristic findings on imaging.

    up to 1 months

  • post pancreatic extracorporeal shock wave lithotripsy (ESWL) pancreatitis

    The main outcome analyzed was the development of post-procedural pancreatitis, which was defined as clinical pancreatitis, meeting two of three the following criteria in accordance with the Revised Atlanta International consensus including pain consistent with AP; amylase or lipase more than 3 times the upper normal limit; characteristic findings on imaging.

    up to 1 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive CP patients treated with both ESWL and subsequent ERCP during the same hospitalization between October 2016 and July 2019 were included.

You may qualify if:

  • Patients diagnosed with chronic pancreatitis and treated with both ESWL and subsequent ERCP

You may not qualify if:

  • Patients with isolated pancreatic tail stone
  • Patients with suspected or established malignancy
  • Patients with pancreatic ascites
  • Patients attending other interventional clinical trials
  • Patients with non-correctable coagulation disorder
  • Patients with pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ru N, Qian YY, Zhu JH, Chen H, Zou WB, Hu LH, Pan J, Guo JY, Li ZS, Liao Z. Post-ESWL and post-ERCP pancreatitis in patients with chronic pancreatitis: Do they share the same risks? J Hepatobiliary Pancreat Sci. 2021 Sep;28(9):778-787. doi: 10.1002/jhbp.1013. Epub 2021 Jul 22.

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 6, 2020

Study Start

October 31, 2016

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

November 6, 2020

Record last verified: 2020-11