Prognostic Factors in Periampullary Tumors and Cysts

December 13, 2021 updated by: Oskar Franklin, Umeå University

Prognostic Factors, Operative Care and Short and Long Term Outcomes for Cysts and Tumors in Pancreas and the Periampullary Region

The project aims at analysing prognostic and predictive factors involved in diagnostics and surgical treatment of cysts and tumors in the pancreas and periampullary region using both clinical data and blood and tissue samples for biomarker development and validation.

Study Overview

Status

Recruiting

Conditions

Detailed Description

From november 2021 an onward, study participants will be prospectively enrolled within the observational study. Before that, study participants are retrospectively enrolled. The study has a broad perspective including studies on clinical outcomes and prognostics based on patient and tumor characteristics.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Umeå, Sweden, 90185
        • Recruiting
        • Surgical Clinic at Umeå University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Oskar Franklin, MD/PhD
        • Sub-Investigator:
          • Asif Halimi, MD/PhD
        • Sub-Investigator:
          • Stina Lindblad, MD
        • Sub-Investigator:
          • Daniel Öhlund, MD/PhD
        • Sub-Investigator:
          • Roberto Valente, MD/PhD
        • Sub-Investigator:
          • Mikael Öman, MD/PhD
        • Sub-Investigator:
          • Chiara Scandavini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that have been recommended or already undergone surgery for a cyst or tumor in the pancreas or periampullary region

Description

Inclusion Criteria:

  • Recommended surgery for tumor or cyst in the pancreas or periampullary region
  • Information avalible in electronic journal files
  • Informed consent (or deceased for retrospective part of the study)

Exclusion Criteria:

  • No informed consent (and still alive at study initiation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 10 years
Overall survival
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 10 years
Clavien-Dindo, Specific procedure related outcomes
10 years
Radical resection
Time Frame: 10 years
Rates of R0 vs R1/2 resections
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Oskar Franklin, MD/PhD, Umea University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Anticipated)

January 1, 2035

Study Completion (Anticipated)

January 1, 2040

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2022

Last Update Submitted That Met QC Criteria

December 13, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UmU-parpanc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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