Long-term Outcomes of Duodenal Adenocarcinoma From a Large Cohort

NCT06443086 | Not Yet Recruiting

• 1 other identifier: NFEC-2024-171
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators will conducted a hospital-based cohort study in our 15-year experience with DA aimed at investigating the long-term outcomes of the patients with DA, along with analyzing the impact of the tumor characteristics, operations and adjuvant therapy on survival outcomes.

Conditions

Gastrointestinal Disease

Outcome Measures

Primary Outcomes (3)

• Median overall survival time

  Median survival is the time it takes half of the individuals in a given study population to reach or exceed a particular end event, calculated from the time an event occurred. Median survival is a statistical index describing the distribution of survival time.

  2009.10-2023.06

• 3-year overall survival rate

  Three-year survival rate, also known as survival rate, refers to the number of patients with a disease who are still alive at the end of three years of follow-up as a percentage of the number of cases observed

  2009.10-2023.06

• 5-year overall survival rate

  Five-year survival rate, also known as survival rate, refers to the number of patients with a disease who are still alive at the end of five years of follow-up as a percentage of the number of cases observed

  2009.10-2023.06

Study Arms (1)

Duodenal carcinoma patients

The patients included in this study were drawn from a hospital-based cohort and included cases diagnosed and treated at the facility. Inclusion criteria were histologically confirmed non-ampulla DA, including all stages of disease at diagnosis. Patients were excluded if they had ampulla cancer or other forms of gastrointestinal cancer, had incomplete medical records, or lost follow-up shortly after diagnosis. This rigorous selection process ensured the homogeneity of the study population and the relevance of the findings to non-ampulla DA.

Procedure: Radical operation and perioperative therapy

Interventions

Radical operation and perioperative therapy PROCEDURE

Surgical intervention, particularly radical excision, was performed for each patient, including the extent of resection and lymph node dissection. Information on adjuvant therapies, such as chemotherapy and radiotherapy, was also recorded, specifying the regimens and durations.

Duodenal carcinoma patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients included in this study were drawn from a hospital-based cohort and included cases diagnosed and treated at the facility. Inclusion criteria were histologically confirmed non-ampulla DA, including all stages of disease at diagnosis. Patients were excluded if they had ampulla cancer or other forms of gastrointestinal cancer, had incomplete medical records, or lost follow-up shortly after diagnosis. This rigorous selection process ensured the homogeneity of the study population and the relevance of the findings to non-ampulla DA.

You may qualify if:

• (1) histologically confirmed non-ampulla DA;

You may not qualify if:

• had other gastrointestinal cancer;
• had incomplete medical records, or lost follow-up shortly after diagnosis;
• refused clinical data collection.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Hao Liu, MD, PhD

  Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Liu, MD, PhD

CONTACT

+86-20-62787626; hao.liu@alumni.uni-heidelberg.de

Study Design

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

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 5, 2024
• Study Start: June 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06