NCT04907266

Brief Summary

Clinical course of chronic pancreatitis is still unpredictable, due to the lack of clinical classification. There is no model to assess disease severity or progression or predict patient outcomes. So we need to validate an objective predictive model - Chronic Pancreatitis Prognosis Score (COPPS) for classification, prognostication and management in Chronic Pancreatitis (CP)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

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

June 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

May 25, 2021

Last Update Submit

May 25, 2021

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (2)

  • Total number of hospitalizations (all reasons)

    Number of times patient admitted in hospital

    12 months

  • Total number of days spent in hospital within 12 months from inclusion

    Number of days spent in hospital

    12 months

Secondary Outcomes (2)

  • pancreatitis related no of readmissions

    12 months

  • pancreatitis-related complications

    12 months

Interventions

Structured QuestionnaireOTHER

A structured proforma to assess outcome

Eligibility Criteria

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

Patient diagnosed with Chronic Pancreatitis visiting OPD/Indoors

You may qualify if:

  • MEETS THE DEFINITION OF CP
  • Not underwent pancreas related endoscopy/surgery earlier
  • Follow up/index visit in our OPD/ward
  • GIVES INFORMED WRITTEN CONSENT

You may not qualify if:

  • Pancreatic carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IPGMER

Kolkata, 700020, India

Location

Related Publications (1)

  • Maheshwari A, Patra PS, Ray S, Dhali GK, Das K. External validation of Chronic Pancreatitis Prognosis Score (COPPS): A prospective cohort study. Dig Liver Dis. 2022 May;54(5):654-662. doi: 10.1016/j.dld.2021.08.022. Epub 2021 Sep 17.

    PMID: 34544675DERIVED

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
Professor, Division of Gastroenterology, School of Digestive and Liver Diseases

Study Record Dates

First Submitted

May 25, 2021

First Posted

May 28, 2021

Study Start

June 1, 2018

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

May 28, 2021

Record last verified: 2021-05

Locations

IN(1)