Prognostic Factors in Periampullary Tumors and Cysts

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155878
• Other study ID #: UmU-parpanc
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: January 1, 2040

Study information

• Verified date: December 2021
• Source: Umeå University
• Contact: Oskar Franklin, MD/PhD
• Phone: +4690785000
• Email: oskar.franklin[@]umu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 1, 2040
• Est. primary completion date: January 1, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Cysts
• Fistula
• Pancreas Cancer
• Pancreas Cyst
• Pancreas Disease
• Pancreas Neoplasm
• Pancreatic Diseases
• Pancreatic Fistula
• Pancreatic Neoplasms
• Periampullary Cancer
• Surgery
• Surgery--Complications

Locations

Country	Name	City	State
Sweden	Surgical Clinic at Umeå University Hospital	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival	10 years
Secondary	Complications	Clavien-Dindo, Specific procedure related outcomes	10 years
Secondary	Radical resection	Rates of R0 vs R1/2 resections	10 years