An Observational Study on the Natural Course of Chronic Pancreatitis

Sponsor
Changhai Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04574297
Collaborator
(none)
798
240

Study Details

Study Description

Brief Summary

To explore the impact on genetic and environmental factors for clinical manifestation, and the progression of chronic pancreatitis, including development of pancreatic insufficiency and other complications.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: smoking and alcohol assumption
  • Diagnostic Test: genetic sequencing

Detailed Description

The present study was an observational study aimed to explore the impact of genetic factors (rare pathogenic variants of CP) and environmental factors(smoking and alcohol assumption) on the clinical manifestation and progression of CP. The observation items included the pain patterns, incidence of complications of CP, pancreatic cancer and death.

Study Design

Study Type:
Observational
Actual Enrollment :
798 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Impact of Genetic and Environmental Factors on the Progression of Chronic Pancreatitis:An Observational Study
Actual Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
May 31, 2020
Anticipated Study Completion Date :
Dec 31, 2030

Outcome Measures

Primary Outcome Measures

  1. the Number of Patients Developing Pancreatic Insufficiency [10 years]

    The primary endpoint was the number of patients developing pancreatic insufficiency, categorised as 1) diabetes and steatorrhea, 2) diabetes only, or 3) steatorrhea only.

Secondary Outcome Measures

  1. Death [20 years]

    all-cause death

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients with a diagnosis of chronic pancreatitis

  • agree to join the study and provide informed consent

Exclusion Criteria:
  • autoimmune pancreatitis

  • pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis

  • the follow-up time less than 2 years

  • patients presenting with diabetes and/or steatorrhea at onset of CP.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Changhai Hospital

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Zhuan Liao, Principal Investigator, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT04574297
Other Study ID Numbers:
  • CP-2011
First Posted:
Oct 5, 2020
Last Update Posted:
Nov 30, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title G+/E+ Group G-/E+ Group G+/E- Group G-/E- Group
Arm/Group Description Genetic factor/s positive and environmental factor/s positive group. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). Genetic factor/s negative and environmental factor/s positive group.Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). Genetic factor/s positive group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). Genetic factor/s negative group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
Period Title: Overall Study
STARTED 180 263 230 125
COMPLETED 180 263 230 125
NOT COMPLETED 0 0 0 0

Baseline Characteristics

Arm/Group Title G+/E+ Group G-/E+ Group G+/E- Group G-/E- Group Total
Arm/Group Description Genetic factor/s positive and environmental factor/s positive group. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). Genetic factor/s negative and environmental factor/s positive group.Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). Genetic factor/s positive group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). Genetic factor/s negative group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). Total of all reporting groups
Overall Participants 180 263 230 125 798
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]
37.5
44.0
17.5
36.0
35.5
Sex: Female, Male (Count of Participants)
Female
7
3.9%
4
1.5%
147
63.9%
81
64.8%
239
29.9%
Male
173
96.1%
259
98.5%
83
36.1%
44
35.2%
559
70.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
Asian
180
100%
263
100%
230
100%
125
100%
798
100%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
Black or African American
0
0%
0
0%
0
0%
0
0%
0
0%
White
0
0%
0
0%
0
0%
0
0%
0
0%
More than one race
0
0%
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
Region of Enrollment (Count of Participants)
China
180
100%
263
100%
230
100%
125
100%
798
100%

Outcome Measures

1. Primary Outcome
Title the Number of Patients Developing Pancreatic Insufficiency
Description The primary endpoint was the number of patients developing pancreatic insufficiency, categorised as 1) diabetes and steatorrhea, 2) diabetes only, or 3) steatorrhea only.
Time Frame 10 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title G+/E+ Group G-/E+ Group G+/E- Group G-/E- Group
Arm/Group Description Genetic factor/s positive and environmental factor/s positive group. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). Genetic factor/s negative and environmental factor/s positive group.Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). Genetic factor/s positive group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). Genetic factor/s negative group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+).
Measure Participants 180 263 230 125
Count of Participants [Participants]
82
45.6%
130
49.4%
55
23.9%
36
28.8%
2. Secondary Outcome
Title Death
Description all-cause death
Time Frame 20 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time Frame 10 years.
Adverse Event Reporting Description The definition of adverse event and/or serious adverse event is in accordance with the clinicaltrials.gov Definitions.
Arm/Group Title G+/E+ Group G-/E+ Group G+/E- Group G-/E- Group
Arm/Group Description genetic factor/s positive and environmental factor/s positive group Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). genetic factor/s negative and environmental factor/s positive group Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). genetic factor/s positive group and environmental factor/s negative Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). genetic factor/s negative group and environmental factor/s negative
All Cause Mortality
G+/E+ Group G-/E+ Group G+/E- Group G-/E- Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 6/180 (3.3%) 9/263 (3.4%) 4/230 (1.7%) 5/125 (4%)
Serious Adverse Events
G+/E+ Group G-/E+ Group G+/E- Group G-/E- Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/180 (0%) 0/263 (0%) 0/230 (0%) 0/125 (0%)
Other (Not Including Serious) Adverse Events
G+/E+ Group G-/E+ Group G+/E- Group G-/E- Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/180 (0%) 0/263 (0%) 0/230 (0%) 0/125 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Zhuan Liao
Organization Changhai Hospital
Phone 86-21-31161004
Email liaozhuan@smmu.edu.cn
Responsible Party:
Zhuan Liao, Principal Investigator, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT04574297
Other Study ID Numbers:
  • CP-2011
First Posted:
Oct 5, 2020
Last Update Posted:
Nov 30, 2021
Last Verified:
Oct 1, 2021