Longitudinal Study on the Evolution Trend and Influencing Factors of Postoperative Reflux of Esophageal Cancer Based on PEPTEST Technique

NCT06509022 | Enrolling By Invitation

• 1 other identifier: NCC4005
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study intends to explore the evolution trend and related factors of postoperative reflux of esophageal cancer based on PEPTEST detection, in order to identify postoperative reflux The main question it aims to answer are: to provide evidence for high-risk groups, improvement of surgical methods for esophageal cancer, and development of health education programs to prevent postoperative reflux. Using convenient sampling method, patients undergoing esophagectomy in thoracic surgery Department of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023 were continuously enrolled. PEPTEST was performed once before surgery, before discharge, 1 month, 3 months, and 6 months after surgery. The incidence of pathological reflux at 5 time points before and after surgery was observed and compared (that is, both T-line and C-line were shown). The trend of pepsin content in saliva before and after operation; The relationship between pathological reflux and surgical factors; The relationship between pathological reflux and life habits after operation; Relationship between pathological regurgitation and demographic characteristics.

Conditions

GASTROINTESTINAL NEOPLASMS

Outcome Measures

Primary Outcomes (1)

• Incidence of pathological regurgitation

  Incidence of pathological regurgitation at 5 time points before and after surgery.

  2023.1.1-2023.12.1

Study Arms (5)

Before surgery

A patient with esophageal cancer before surgery

Diagnostic Test: PEPTEST test

Before discharge

Patients with esophageal cancer who were not discharged after surgery

Diagnostic Test: PEPTEST test

1 month after surgery

One month after surgery for esophageal cancer

Diagnostic Test: PEPTEST test

3 months after surgery

Three months after surgery for esophageal cancer

Diagnostic Test: PEPTEST test

6 months after surgery

Six months after surgery for esophageal cancer

Diagnostic Test: PEPTEST test

Interventions

PEPTEST test DIAGNOSTIC_TEST

Quantitative determination of gastric salivary amylase。

1 month after surgery; 3 months after surgery; 6 months after surgery; Before discharge; Before surgery

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 who underwent resection for esophageal cancer were continuously enrolled.

You may qualify if:

• Patients who were pathologically diagnosed with esophageal cancer and underwent esophagectomy for esophageal cancer.
• The patient can communicate in Mandarin.
• Those who can come to the hospital for review on time.

You may not qualify if:

• People with cognitive impairment or mental illness.
• Complicating other serious life-threatening diseases (such as leukemia or autoimmune diseases).
• Unwilling to participate in the study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: July 19, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)