Esophageal CancerNCT05342805
Comparison of Subtotal Stomach and Narrow Gastric Tube After Esophagectomy
A study testing Narrow gastric tube in people with Esophageal Cancer, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Narrow gastric tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteVietnam
- Study dates
- 3 May 2022to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000
About this study
Official title: Comparison of Subtotal Stomach and Narrow Gastric Tube for Reconstruction After Esophagectomy for Gastric Cancer: a Prospective Randomized Control Trial
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.
Read the detailed description
Stomach is the most common esophageal subtitute after a esophagectomy procedure, because it has a abundant blood supply and the need for only one anastomosis. However, cervical esophago-gastro anastomosis still has a high risk of complications, especially anastomosis leakage (11.9 - 25 % ).
There are three types of gastric subtitute: whole stomach, subtotal stomach and narrow gastric tube. While whole stomach and subtotal stomach has an advantage in the submucosal vascular network, a narrow tube is excellent elasticity and the ease with which it can be pulled up into the neck without tension, that could affect leakage rate.
On the other hand, after esophagectomy, nutrition status and quality of life (QoL) had decreased due to effect of adjuvant therapy, lower quantity of food intake, gastro-esophageal reflux and other postoperative syndromes. Several studies had shown the affect of the width of gastric tube to the postoperative nutrition and QoL, however, the results were not homogenous. This study aims to compared two types of gastric subtitute after esophagectomy: subtotal stomach and narrow gastric tube
- Conditions
- Esophageal Cancer
- Being tested
- Narrow gastric tube
- Keywords
- subtotal stomach, narrow gastric tube, anastomosis
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow gastric tubeProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Subtotal stomach | Experimental | The 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. Receives: Procedure: Narrow gastric tube |
| Narrow gastric tube | Active comparator | 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. Receives: Procedure: Narrow gastric tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days after surgery
Early outcomes (30-day post operative): length of hospital stay.
Comparison of the length of hospital stay.
Measured: 30 days after surgery
Early outcomes (30-day post operative): day of oral intake.
Comparison of the day of oral intake.
Measured: 30 days after surgery
Secondary outcomes (13)
Postoperative nutritional status: body weight
Comparison of body weight at 6, 12 months and every year after surgery
Measured: 6, 12 months and 1 year after surgery
Postoperative nutritional status: serum total protein
Comparison of serum total protein at 6, 12 months and every year after surgery
Measured: 6, 12 months and 1 year after surgery
Postoperative nutritional status: albumin level
Comparison of albumin level at 6, 12 months and every year after surgery
Measured: 6, 12 months and 1 year after surgery
Postoperative nutritional status: hemoglobin
Comparison of hemoglobin at 6, 12 months and every year after surgery
Measured: 6, 12 months and 1 year after surgery
Reflux esophagitis
Reflux esophagitis will be evaluated using the Los Angeles classification at 6, 12 months and every year after surgery
Measured: 6, 12 months and 1 year after surgery
Residue Gastritis Bile
RGB (Residue Gastritis Bile) classification will be used to evaluate status of remnant stomach 6 to 12 months after surgery
Measured: 6, 12 months and 1 year after
Patients' health-related quality of life
Patients' health-related quality of life will be evaluated using GSRS (Gastrointestinal Symptom Rating Scale) score at 6, 12 months and every year after surgery
Measured: 6, 12 months and 1 year after
Late complications: anastomotic stricture
Comparison of the rate anastomotic stricture complications during the follow-up period
Measured: 6, 12 months and 1 year after
Late complications: anastomotic ulcer
Comparison of anastomotic ulcer during the follow-up period
Measured: 6, 12 months and 1 year after
Others late complications
Comparison of other late complications during the follow-up period
Measured: 6, 12 months and 1 year after
Oncological outcomes: overall survival rate
Comparison of overall survival rate during the follow-up period
Measured: 6, 12 months and 1 year after
Oncological outcomes: rate of death due to the cancer
Comparison of rate of death due to the cancer, and death from all causes during the follow-up period
Measured: 6, 12 months and 1 year after
Oncological outcomes: recurrence, metastasis
Comparison of recurrence, metastasis during the follow-up period
Measured: 6, 12 months and 1 year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start3 May 2022 (estimated)
- Primary completion15 Apr 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Long D Vo, MD, PhD, Study director, University Medical Center, HCMC, VN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342805
- Sponsor's protocol ID
- 16/GCN-HDDD 2022
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Subtotal Stomach and Narrow Gastric Tube for Reconstruction After Esophagectomy for Gastric Cancer: a Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05342805
- Acronym / sponsor ID
- 16/GCN-HDDD 2022
- Conditions
- Esophageal Cancer
- Keywords
- subtotal stomach, narrow gastric tube, anastomosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 3 May 2022 (estimated)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stomach is the most common esophageal subtitute after a esophagectomy procedure, because it has a abundant blood supply and the need for only one anastomosis. However, cervical esophago-gastro anastomosis still has a high risk of complications, especially anastomosis leakage (11.9 - 25 % ).
There are three types of gastric subtitute: whole stomach, subtotal stomach and narrow gastric tube. While whole stomach and subtotal stomach has an advantage in the submucosal vascular network, a narrow tube is excellent elasticity and the ease with which it can be pulled up into the neck without tension, that could affect leakage rate.
On the other hand, after esophagectomy, nutrition status and quality of life (QoL) had decreased due to effect of adjuvant therapy, lower quantity of food intake, gastro-esophageal reflux and other postoperative syndromes. Several studies had shown the affect of the width of gastric tube to the postoperative nutrition and QoL, however, the results were not homogenous. This study aims to compared two types of gastric subtitute after esophagectomy: subtotal stomach and narrow gastric tube
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subtotal stomach | Experimental | Procedure: Narrow gastric tubeThe 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 comparator | Procedure: Narrow gastric tubeAt 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrow gastric tubeAt 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 | Procedure or surgery | Narrow gastric tube, Subtotal stomach |
Primary outcome
Early complications (30-day complications): rate of anastomotic leakage
Time frame: 30 days after surgery
Comparison of the rate of anastomotic leakage. All complications will be classified according to the Clavien-Dindo classification.
Early complications (30-day complications): rate of anastomotic stricture
Time frame: 30 days after surgery
Comparison of the rate of anastomotic stricture. All complications will be classified according to the Clavien-Dindo classification.
Early complications (30-day complications): rate of bleeding
Time frame: 30 days after surgery
Comparison of the rate of bleeding. All complications will be classified according to the Clavien-Dindo classification.
Early complications (30-day complications): rate of pneumonia
Time frame: 30 days after surgery
Comparison of the rate of pneumonia. All complications will be classified according to the Clavien-Dindo classification.
Early complications (30-day complications): rate of mortality.
Time frame: 30 days after surgery
Comparison of the rate of anastomotic leakage. All complications will be classified according to the Clavien-Dindo classification.
Early complications (30-day complications): rate of reoperation.
Time frame: 30 days after surgery
Comparison of the rate of reoperation. All complications will be classified according to the Clavien-Dindo classification.
Early outcomes (30-day post operative): length of hospital stay.
Time frame: 30 days after surgery
Comparison of the length of hospital stay.
Early outcomes (30-day post operative): day of oral intake.
Time frame: 30 days after surgery
Comparison of the day of oral intake.
13 secondary outcomes
Postoperative nutritional status: body weight
Time frame: 6, 12 months and 1 year after surgery
Postoperative nutritional status: serum total protein
Time frame: 6, 12 months and 1 year after surgery
Postoperative nutritional status: albumin level
Time frame: 6, 12 months and 1 year after surgery
Postoperative nutritional status: hemoglobin
Time frame: 6, 12 months and 1 year after surgery
Reflux esophagitis
Time frame: 6, 12 months and 1 year after surgery
Residue Gastritis Bile
Time frame: 6, 12 months and 1 year after
Patients' health-related quality of life
Time frame: 6, 12 months and 1 year after
Late complications: anastomotic stricture
Time frame: 6, 12 months and 1 year after
Late complications: anastomotic ulcer
Time frame: 6, 12 months and 1 year after
Others late complications
Time frame: 6, 12 months and 1 year after
Oncological outcomes: overall survival rate
Time frame: 6, 12 months and 1 year after
Oncological outcomes: rate of death due to the cancer
Time frame: 6, 12 months and 1 year after
Oncological outcomes: recurrence, metastasis
Time frame: 6, 12 months and 1 year after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Long D Vo, MD, PhD study director
University Medical Center, HCMC, VN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow gastric tube in people with Esophageal Cancer, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Long D Vo, MD, PhD (+84. 918 133 915, long.vd@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early complications (30-day complications): rate of anastomotic leakage (time frame: 30 days after surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.