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

NCT ID: NCT06509022

Last Updated: 2024-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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.

Conditions

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GASTROINTESTINAL NEOPLASMS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Before surgery

A patient with esophageal cancer before surgery

PEPTEST test

Intervention Type DIAGNOSTIC_TEST

Quantitative determination of gastric salivary amylase。

Before discharge

Patients with esophageal cancer who were not discharged after surgery

PEPTEST test

Intervention Type DIAGNOSTIC_TEST

Quantitative determination of gastric salivary amylase。

1 month after surgery

One month after surgery for esophageal cancer

PEPTEST test

Intervention Type DIAGNOSTIC_TEST

Quantitative determination of gastric salivary amylase。

3 months after surgery

Three months after surgery for esophageal cancer

PEPTEST test

Intervention Type DIAGNOSTIC_TEST

Quantitative determination of gastric salivary amylase。

6 months after surgery

Six months after surgery for esophageal cancer

PEPTEST test

Intervention Type DIAGNOSTIC_TEST

Quantitative determination of gastric salivary amylase。

Interventions

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PEPTEST test

Quantitative determination of gastric salivary amylase。

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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NCC4005

Identifier Type: -

Identifier Source: org_study_id

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