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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

PEPTEST test

Diagnostic Test

Quantitative determination of gastric salivary amylase。

Primary outcomes

Incidence of pathological regurgitation

Time frame: 2023.1.1-2023.12.1

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

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

China Cancer Foundation Beijing Hope Marathon Fund

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jul 19, 2024
Registry last updated: Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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