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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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06509022
Enrollment
138
Registered
2024-07-19
Start date
2024-03-01
Completion date
2026-12-01
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GASTROINTESTINAL NEOPLASMS

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.

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.

Interventions

DIAGNOSTIC_TESTPEPTEST test

Quantitative determination of gastric salivary amylase。

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of pathological regurgitation2023.1.1-2023.12.1Incidence of pathological regurgitation at 5 time points before and after surgery.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026