Surgical Outcome and Predictors of Overall Survival of Stage I-III Appendiceal Adenocarcinoma

NCT05452382 | Completed

• 1 other identifier: NCDBAppendix
• Study Type: observational
• Target: 2,607
• Locations: 1 country
• Sites: 1

Brief Summary

A few studies investigated the predictors of overall survival in appendiceal adenocarcinoma. A SEER database analysis of 1404 patients with appendiceal adenocarcinoma found that older age, T4 tumors, N1-2 stage, poorly differentiated carcinoma, and distant metastasis were significantly predictive of poorer survival. Another small single-center study including 49 appendiceal cancer patients reported female gender and low-grade adenocarcinoma to be associated with increased overall survival. However, these previous analyses did not take into account some important prognosticators of survival such as patients' comorbidities and functional status, pathologic parameters such as lymphovascular invasion, and adjuvant systemic treatment. Therefore, we used the National Cancer Database (NCDB) to conduct a comprehensive analysis of the predictors of overall survival after surgical treatment of stage I-III appendiceal adenocarcinoma.

Conditions

Appendiceal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Percent of patients who were alive at five years of follow-up

  60 months

Secondary Outcomes (1)

• Positive resection margins

  Immediate postoperative

Study Arms (2)

Partial colectomy

Patients with appendiceal cancer who underwent segmental resection of appendiceal adenocarcinoma

Procedure: Partial colecctomy

Hemicolectomy

Patients with appendiceal cancer who underwent formal right hemicolectomy of appendiceal adenocarcinoma

Procedure: Hemicolectomy

Interventions

Partial colecctomy PROCEDURE

Segmental resection of appendiceal adenocarcinoma including terminal ileum and cecum

Partial colectomy

Hemicolectomy PROCEDURE

Formal right hemicolectomy including terminal ileum, cecum, and ascending colon

Hemicolectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage I-III appendiceal adenocarcinoma

You may qualify if:

• patients with non-metastatic appendiceal adenocarcinoma who underwent surgical resection

You may not qualify if:

• Patients with other pathologic types of appendiceal cancer
• Patients with clinical stage IV or unknown stage
• Patients who did not undergo surgery, underwent local excision, or had unknown/non-specified surgery

Sponsors & Collaborators

• Mansoura University: lead
• Cleveland Clinic Florida: collaborator

Study Sites (1)

Cleveland Clinic Flroida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Appendiceal Neoplasms

Interventions

Colectomy

Condition Hierarchy (Ancestors)

Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research associate

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: January 1, 2005
• Primary Completion: December 30, 2019
• Study Completion: July 6, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)