Comparison of Subtotal Stomach and Narrow Gastric Tube After Esophagectomy
1 other identifier
interventional
50
1 country
1
Brief Summary
Currently, both the subtotal stomach and narrow gastric tube approaches are widely used for esophagogastric anastomosis after esophagectomy. Some stud- ies have concluded that the subtotal gastric conduit is superior to the wide gastric-tube approach, as it provides better protection of the submucosal vessels and can slightly increase gastric capacity. Furthermore, blood perfusion significantly decreases after tubular gastric surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedStudy Start
First participant enrolled
May 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedApril 28, 2022
April 1, 2022
2 years
April 8, 2022
April 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Early complications (30-day complications): rate of anastomotic leakage
Comparison of the rate of anastomotic leakage. All complications will be classified according to the Clavien-Dindo classification.
30 days after surgery
Early complications (30-day complications): rate of anastomotic stricture
Comparison of the rate of anastomotic stricture. All complications will be classified according to the Clavien-Dindo classification.
30 days after surgery
Early complications (30-day complications): rate of bleeding
Comparison of the rate of bleeding. All complications will be classified according to the Clavien-Dindo classification.
30 days after surgery
Early complications (30-day complications): rate of pneumonia
Comparison of the rate of pneumonia. All complications will be classified according to the Clavien-Dindo classification.
30 days after surgery
Early complications (30-day complications): rate of mortality.
Comparison of the rate of anastomotic leakage. All complications will be classified according to the Clavien-Dindo classification.
30 days after surgery
Early complications (30-day complications): rate of reoperation.
Comparison of the rate of reoperation. All complications will be classified according to the Clavien-Dindo classification.
30 days after surgery
Early outcomes (30-day post operative): length of hospital stay.
Comparison of the length of hospital stay.
30 days after surgery
Early outcomes (30-day post operative): day of oral intake.
Comparison of the day of oral intake.
30 days after surgery
Secondary Outcomes (13)
Postoperative nutritional status: body weight
6, 12 months and 1 year after surgery
Postoperative nutritional status: serum total protein
6, 12 months and 1 year after surgery
Postoperative nutritional status: albumin level
6, 12 months and 1 year after surgery
Postoperative nutritional status: hemoglobin
6, 12 months and 1 year after surgery
Reflux esophagitis
6, 12 months and 1 year after surgery
- +8 more secondary outcomes
Study Arms (2)
Subtotal stomach
EXPERIMENTALThe vessels at the anastomosis of right and left gastric arteries were separated, then the proximal haft of lesser curvature and cardia was resected using linear staplers.
Narrow gastric tube
ACTIVE COMPARATORAt the lesser curvature, the resection began at the point that was 5-cm from the pyloric, toward to the greater curvature, then the stomach was divided along 3 cm from the greater curvature using linear stapler.
Interventions
At the lesser curvature, the resection began at the point that was 5-cm from the pyloric, toward to the greater curvature, then the stomach was divided along 3 cm from the greater curvature using linear stapler
Eligibility Criteria
You may qualify if:
- Pathologic finding by esophageal endoscopy: confirmed esophageal cancer.
- Indication for esophagectomy
- Age: 18 - 80 year old
- Tumor located at the middle or lower third of the esophagus
- ASA score: ≤ 3
- Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)
You may not qualify if:
- Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed esophageal cancer
- Pregnant patient
- Using colon or intesinal conduit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Long D Vo, MD, PhD
University Medical Center, HCMC, VN
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2022
First Posted
April 25, 2022
Study Start
May 3, 2022
Primary Completion
April 15, 2024
Study Completion
August 30, 2024
Last Updated
April 28, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share