- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06741124
Comparison of Channel Esophagogastrostomy and Double Tract Reconstruction After Laparoscopic-assist Proximal Gastrectomy: a Propensity Score-Matched Analysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Yangzhou City, Jiangsu, China, 225001
- Northern Jiangsu People's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
(1) Patients with a malignant tumor in the upper one-third of the stomach, diagnosed through endoscopy and pathology, with no distant metastases confirmed by multislice spiral computed tomography, and who underwent elective LAPG; (2) Patients who underwent CE reconstruction or DTR during LAPG; and (3) Patients available for postoperative follow-up.
Exclusion Criteria:
(1) Patients who had received neoadjuvant radiotherapy or chemotherapy prior to surgery; (2) Emergency surgery patients; (3) Patients with concurrent malignancies; (4) Lost to follow-up patients.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Channel Esophagogastrostomy (CE)
Patients who underwent Channel Esophagogastrostomy reconstruction
|
Channel Esophagogastrostomy
|
|
Double Tract Reconstruction (DTR)
Patients who underwent DTR reconstruction during LAPG
|
Double Tract Reconstruction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endoscopic reflux esophagitis
Time Frame: Postoperative one year
|
Los Angeles classification
|
Postoperative one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PGSAS-45 questionnaires
Time Frame: Postoperative one year
|
Postgastrectomy syndrome assessment scale (PGSAS-45) developed by the Japanese Post-Gastrectomy Symptom Assessment Study Group, is used to objectively evaluate postoperative symptom, quality of life of patients after gastrectomy.
It reflects symptoms in seven areas: gastroesophageal reflux, abdominal pain, meal-related distress, dyspepsia, diarrhea, constipation, and dumping syndrome.
|
Postoperative one year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutritions status
Time Frame: Postoperative one month, Postoperative three month, Postoperative nine month, Postoperative twelve month,
|
alb, hb,
|
Postoperative one month, Postoperative three month, Postoperative nine month, Postoperative twelve month,
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NorthernJiangsuCEDTR
- CEDTR (Other Identifier: CEDTR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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