NCT03324698

Brief Summary

Chronic pancreatitis (CP) is a disease characterized by inflammation and their replacement by fibrotic tissue. The destruction of pancreatic function and structure are the main complications. This retrospective-prospective, multicenter, cohort study was conducted. This study aimed to observe the natural history of CP in China, analyse the risk factors for CP complications, and establish individual predictions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2000

Completed
17.8 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

18 years

First QC Date

October 25, 2017

Last Update Submit

October 27, 2017

Conditions

Chronic PancreatitisComplicationRisk Factors

Outcome Measures

Primary Outcomes (5)

  • Pancreatic cancer

    Pancreatic cancer developed in chronic pancreatitis patients

    Dec 31, 2017

  • Diabetes mellitus

    Endocrine insufficiency developed in chronic pancreatitis patients

    Dec 31, 2017

  • Steatorrhea

    Exocrine insufficiency developed in chronic pancreatitis patients

    Dec 31, 2017

  • Pancreatic pseudocyst

    Pancreatic pseudocyst developed in chronic pancreatitis patients

    Dec 31, 2017

  • Common bile duct stricture

    Common bile duct stricture developed in chronic pancreatitis patients

    Dec 31, 2017

Eligibility Criteria

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

Chronic pancreatitis patients in China

You may qualify if:

  • Patients diagnosed with chronic pancreatitis according to Asia-Pacific consensus

You may not qualify if:

  • Pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis
  • Groove pancreatitis
  • Autoimmune pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

Location

Related Publications (4)

  • Li BR, Pan J, Du TT, Liao Z, Ye B, Zou WB, Chen H, Ji JT, Zheng ZH, Wang D, Lin JH, Ning SB, Hu LH, Li ZS. Risk Factors for Steatorrhea in Chronic Pancreatitis: A Cohort of 2,153 Patients. Sci Rep. 2016 Feb 15;6:21381. doi: 10.1038/srep21381.

    PMID: 26877248BACKGROUND

  • Hao L, Pan J, Wang D, Bi YW, Ji JT, Xin L, Liao Z, Du TT, Lin JH, Zhang D, Zeng XP, Ye B, Zou WB, Chen H, Xie T, Li BR, Zheng ZH, Hu LH, Li ZS. Risk factors and nomogram for pancreatic pseudocysts in chronic pancreatitis: A cohort of 1998 patients. J Gastroenterol Hepatol. 2017 Jul;32(7):1403-1411. doi: 10.1111/jgh.13748.

    PMID: 28127800BACKGROUND

  • Hao L, Zeng XP, Xin L, Wang D, Pan J, Bi YW, Ji JT, Du TT, Lin JH, Zhang D, Ye B, Zou WB, Chen H, Xie T, Li BR, Zheng ZH, Wang T, Guo HL, Liao Z, Li ZS, Hu LH. Incidence of and risk factors for pancreatic cancer in chronic pancreatitis: A cohort of 1656 patients. Dig Liver Dis. 2017 Nov;49(11):1249-1256. doi: 10.1016/j.dld.2017.07.001. Epub 2017 Jul 15.

    PMID: 28756974BACKGROUND

  • Hao L, Bi YW, Zhang D, Zeng XP, Xin L, Pan J, Wang D, Ji JT, Du TT, Lin JH, Ye B, Zou WB, Chen H, Xie T, Li BR, Zheng ZH, Wang T, Guo HL, Liao Z, Li ZS, Hu LH. Risk Factors and Nomogram for Common Bile Duct Stricture in Chronic Pancreatitis: A Cohort of 2153 Patients. J Clin Gastroenterol. 2019 Mar;53(3):e91-e100. doi: 10.1097/MCG.0000000000000930.

    PMID: 28961573BACKGROUND

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
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology Dept.

Study Record Dates

First Submitted

October 25, 2017

First Posted

October 30, 2017

Study Start

January 1, 2000

Primary Completion

December 31, 2017

Study Completion

August 31, 2018

Last Updated

October 30, 2017

Record last verified: 2017-10

Locations

CN(1)