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

Surgical Outcome and Predictors of Overall Survival of Stage I-III Appendiceal Adenocarcinoma; a National Cancer Database Analysis

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.

Study Overview

• Status: Completed
• Conditions: Appendiceal Cancer
• Intervention / Treatment: Procedure: Partial colecctomy; Procedure: Hemicolectomy

• Study Type: Observational
• Enrollment (Actual): 2607

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Flroida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with stage I-III appendiceal adenocarcinoma

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Partial colectomy; Patients with appendiceal cancer who underwent segmental resection of appendiceal adenocarcinoma	Procedure: Partial colecctomy; Segmental resection of appendiceal adenocarcinoma including terminal ileum and cecum
Hemicolectomy; Patients with appendiceal cancer who underwent formal right hemicolectomy of appendiceal adenocarcinoma	Procedure: Hemicolectomy; Formal right hemicolectomy including terminal ileum, cecum, and ascending colon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Percent of patients who were alive at five years of follow-up	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive resection margins	the rate of surgical margins infiltrated by malignancy	Immediate postoperative

Collaborators and Investigators

• Sponsor: Mansoura University
• Collaborators: Cleveland Clinic Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2005
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): July 6, 2022

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Cecal Diseases; Cecal Neoplasms; Adenocarcinoma; Appendiceal Neoplasms
• Other Study ID Numbers: NCDBAppendix

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No