Long-term Outcomes of Duodenal Adenocarcinoma From a Large Cohort

Gastrointestinal Disease Clinical Trial

Official title:

Long-term Survival Outcomes of Duodenal Adenocarcinoma: a Cohort Study With 15-year Single-center Experience

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06443086
• Other study ID #: NFEC-2024-171
• Status: Not yet recruiting
• Start date: June 15, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: Nanfang Hospital, Southern Medical University
• Contact: Hao Liu, MD, PhD
• Phone: +86-20-62787626
• Email: hao.liu[@]alumni.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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