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

China Cancer Foundation Beijing Hope Marathon Fund

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: GASTROINTESTINAL NEOPLASMS
• Intervention / Treatment: Diagnostic test: PEPTEST test

Detailed Description

The subjects of this study were selected from the patients who underwent esophagectomy in the Department of Thoracic Surgery of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023 to December 1, 2023, and the patients who underwent esophagectomy in the Department of thoracic surgery of Cancer Hospital of Chinese Academy of Medical Sciences from January 1, 2023. PEPTEST was performed once before surgery, before discharge, 1 month, 3 months, and 6 months after surgery. To describe the evolution trend of postoperative reflux in patients with esophageal cancer can be used for anticipatory sexual health education. To explore the relevant factors of reflux: to identify the inherent factors, such as gender, BMI, etc., to give preventive intervention to high-risk groups; The variable factors such as the length and width of the tube stomach can be improved.

• Study Type: Observational
• Enrollment (Estimated): 138

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent resection for esophageal cancer were continuously enrolled.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before surgery; A patient with esophageal cancer before surgery	Diagnostic test: PEPTEST test; Quantitative determination of gastric salivary amylase。
Before discharge; Patients with esophageal cancer who were not discharged after surgery	Diagnostic test: PEPTEST test; Quantitative determination of gastric salivary amylase。
1 month after surgery; One month after surgery for esophageal cancer	Diagnostic test: PEPTEST test; Quantitative determination of gastric salivary amylase。
3 months after surgery; Three months after surgery for esophageal cancer	Diagnostic test: PEPTEST test; Quantitative determination of gastric salivary amylase。
6 months after surgery; Six months after surgery for esophageal cancer	Diagnostic test: PEPTEST test; Quantitative determination of gastric salivary amylase。

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pathological regurgitation	Incidence of pathological regurgitation at 5 time points before and after surgery.	2023.1.1-2023.12.1

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 26, 2023
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: NCC4005

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