Long-term Outcomes of Duodenal Adenocarcinoma From a Large Cohort

NCT ID: NCT06443086

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2024-12-30

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.

Detailed Description

Numerous meta-analyses and systematic reviews have delved into the treatment of DA, yet the majority of the studies retrospective, single-center, and small sample size series, particularly in China. To bridge this knowledge gap, the investigators will conduct a hospital-based cohort study designed to investigate the long-term survival outcomes of the participants with the non-ampulla duodenal adenocarcinoma, and the effects of tumor characteristics, surgery, and adjuvant therapy on survival outcomes.

Conditions

Gastrointestinal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Radical operation and perioperative therapy

Intervention Type: 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.

Interventions

Radical operation and perioperative therapy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

(1) histologically confirmed non-ampulla DA;

Exclusion Criteria

1. had other gastrointestinal cancer;

2. had incomplete medical records, or lost follow-up shortly after diagnosis;

3. refused clinical data collection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hao Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

Hao Liu, MD, PhD

Role: CONTACT

hao.liu@alumni.uni-heidelberg.de

+86-20-62787626

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NFEC-2024-171

Identifier Type: -

Identifier Source: org_study_id