Trial Outcomes & Findings for An Observational Study on the Natural Course of Chronic Pancreatitis (NCT NCT04574297)

NCT ID: NCT04574297

Last Updated: 2021-11-30

Results Overview

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

• Recruitment status: ACTIVE_NOT_RECRUITING
• Target enrollment: 798 participants
• Primary outcome timeframe: 10 years
• Results posted on: 2021-11-30

Participant Flow

Participant milestones

Measure	G+/E+ Group 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+).	G-/E+ Group 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+).	G+/E- Group 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+).	G-/E- Group 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+).
Overall Study STARTED	180	263	230	125
Overall Study COMPLETED	180	263	230	125
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational Study on the Natural Course of Chronic Pancreatitis

Baseline characteristics by cohort

Measure	G+/E+ Group n=180 Participants 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+).	G-/E+ Group n=263 Participants 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+).	G+/E- Group n=230 Participants 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+).	G-/E- Group n=125 Participants 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 n=798 Participants Total of all reporting groups
Age, Continuous	37.5 years n=5 Participants	44.0 years n=7 Participants	17.5 years n=5 Participants	36.0 years n=4 Participants	35.5 years n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	147 Participants n=5 Participants	81 Participants n=4 Participants	239 Participants n=21 Participants
Sex: Female, Male Male	173 Participants n=5 Participants	259 Participants n=7 Participants	83 Participants n=5 Participants	44 Participants n=4 Participants	559 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	180 Participants n=5 Participants	263 Participants n=7 Participants	230 Participants n=5 Participants	125 Participants n=4 Participants	798 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment China	180 Participants n=5 Participants	263 Participants n=7 Participants	230 Participants n=5 Participants	125 Participants n=4 Participants	798 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	G+/E+ Group n=180 Participants 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+).	G-/E+ Group n=263 Participants 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+).	G+/E- Group n=230 Participants 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+).	G-/E- Group n=125 Participants 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+).
the Number of Patients Developing Pancreatic Insufficiency	82 Participants	130 Participants	55 Participants	36 Participants

SECONDARY outcome

Timeframe: 20 years

all-cause death

Outcome measures

Outcome data not reported

Adverse Events

G+/E+ Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

G-/E+ Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

G+/E- Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

G-/E- Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Zhuan Liao

Changhai Hospital

Phone: 86-21-31161004

Email: liaozhuan@smmu.edu.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place