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NCT Number: NCT03324698

The Natural History of Chronic Pancreatitis

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Complication Digestive System Diseases Disease Attributes Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Risk Factors

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

About this study

In order to track changes consistently throughout the course of CP and facilitate the evaluation and study of CP, a dedicated database, CP Database (version number 2.1, YINMA Information Technology Inc., Shanghai, China), was established to collect clinical data of CP patients who were admitted to our centers. Data befor CP Database established were retrospectively collected according to the electronic medical record system and complemented through telephone, letter, and e-mail inquiries. Data were prospectively collected since CP Database was established. The following information was documented in detail: demographic data (age, sex, birthplace, et al), course of CP, medical history, history of other diseases, smoking and alcohol history, family history of pancreatic diseases and diabetes mellitus (DM), laboratory and imaging findings, and treatment strategy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Pancreatic cancer

    Time frame: Dec 31, 2017

    Pancreatic cancer developed in chronic pancreatitis patients

  2. Diabetes mellitus

    Time frame: Dec 31, 2017

    Endocrine insufficiency developed in chronic pancreatitis patients

  3. Steatorrhea

    Time frame: Dec 31, 2017

    Exocrine insufficiency developed in chronic pancreatitis patients

  4. Pancreatic pseudocyst

    Time frame: Dec 31, 2017

    Pancreatic pseudocyst developed in chronic pancreatitis patients

  5. Common bile duct stricture

    Time frame: Dec 31, 2017

    Common bile duct stricture developed in chronic pancreatitis patients

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • 900th Hospital of PLA Joint Logistic Support Force
  • Air Force Medical Center of PLA
  • Jinling Hospital, China
  • Ruijin Hospital
  • Shenzhen People's Hospital
  • The Affiliated Hospital of Qingdao University
  • The Affiliated Hospital of Technical University of Munich
  • The Fifth Medical Center of Chinese People's Liberation Army General Hospital
  • The Fifth Medical Center of the PLA General Hospital
  • The First People's Hospital of Hefei
  • The Third People's Hospital of Chengdu
  • Yangzhou University
  • Zaozhuang Central Hospital of Shandong Health Group
  • Zhongda Hospital

Registry information

Official study title

The Natural History of Chronic Pancreatitis: A Multicenter Study

Important dates

Study start
2000
Primary completion
2026
Study completion
2027
First posted
Oct 30, 2017
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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