Pancreatic Fibrosis as a Prognostic Factor

NCT05775107 | Unknown

• 1 other identifier: 4/2022
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In chronic pancreatitis, pancreatic fibrosis impairs the ducts patency and secretion and contributes to chronic pain. Another complication of long CP presence is pancreatic exocrine insufficiency (PEI) that is present in 30-90% of patients with CP. Currently, there are no reliable techniques for non-invasive assessment of the pancreatic fibrosis degree. The only accurate method for determining the severity of fibrotic changes in the pancreas is histological examination. Despite the high informativeness of this method, its use is limited by the necessity to obtain biopsy specimens of sufficient diagnostic volume or surgical material, which is associated with the complications risk of an invasive procedure. This makes it impossible to assess the degree of fibrosis in all the patients with pancreatic diseases. It is possible to overcome the limitations by applying non-invasive diagnostic techniques, the development and grounding of which is planned within the framework of the Project.

Conditions

Pancreatic Fibrosis

Keywords

pancreatic fibrosis

Outcome Measures

Primary Outcomes (1)

• correlation between non-invasive and invasive markers of pancreatic fibrosis

  fibrotic changes according to the histological examination can be comparable to the degree of fibrosis of the pancreas identified by non-invasive radiology and laboratory diagnostic methods

  3 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients with pre-planned pancreatic resection

You may qualify if:

• age 18-99 years
• pre-planned pancreatic resection
• consent of the patient to participate in the study

You may not qualify if:

• the impossibility of obtaining clinical data, data of instrumental, laboratory studies, and histological examination of the material obtained during surgical treatment.

Sponsors & Collaborators

• Moscow Clinical Scientific Center: lead

Study Sites (1)

A.S. Loginov Moscow Clinical Scientific Center

Moscow, Russia

RECRUITING

Related Publications (15)

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Related Links

• Matteo de Pastena, Eduard A van Bodegraven, Marc G Besselink, Claudio Bassi

Biospecimen

Retention: SAMPLES WITH DNA

pancreatic tissue from organ complex acquired diring pancreatic resections

Study Officials

• Dmitry S. Bordin, MD PhD

  A.S. Loginov Moscow Clinical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitry Bordin

CONTACT

+79262311603; d.bordin@mknc.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: July 1, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

RU (1)