Gastric CancerNCT03613142
Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy
A study testing Double tract anatomosis and Esophagogastrostomy in people with Gastric Cancer and GastroEsophageal Cancer, run by Peking University Cancer Hospital & Institute.
Trial summary
The patients with upper gastric cancer (cT1N0M0) or gastroesophageal adenocarcinoma (diameter less than 4 cm) will be enrolled into this study. Each of these patients will undergo radical proximal gastrectomy and be randomly allocated into one of the two groups, double tract anastomosis group or esophagogastrostomy… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, GastroEsophageal Cancer
- What is being tested?
- Double tract anatomosis and Esophagogastrostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 30 Dec 2021
- 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
- Patients diagnosed as gastric or esophagogastric adenocarcinoma
- Age ranges from 18 to 80
- Karnofsky assessment no less than 70
- Completion of abdominal CT scan and ultrasound endoscopy
- Upper gastric cancer (cT1N0M0) or esophagogastric adenocarcinoma (diameter no more than 4 cm)
- radical proximal gastrectomy
- Normal blood routine examination and biochemical test
Who cannot join
- Patients need to undergo total gastrectomy or distal gastrectomy
- Female patients with pregnancy
- Not suitable for operation
- Patients have already joined other clinical trials
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy: A Prospective, Randomized, Controlled Study
The patients with upper gastric cancer (cT1N0M0) or gastroesophageal adenocarcinoma (diameter less than 4 cm) will be enrolled into this study. Each of these patients will undergo radical proximal gastrectomy and be randomly allocated into one of the two groups, double tract anastomosis group or esophagogastrostomy group. The following data will be collected to compare the difference between the two reconstruction methods: the rate of reflux esophagitis, postoperative quality of life, economic expenditure, the safety of operation, postoperative recovery, postoperative nutrition status and oncological effect. Through the comprehensive analysis, the result of this study will elucidate the best of the reconstruction method after proximal gastrectomy.
- Conditions
- Gastric Cancer, GastroEsophageal Cancer
- Being tested
- Double tract anatomosis, Esophagogastrostomy
- Keywords
- Double tract, Esophagogastrostomy, Gastric cancer, GastroEsophageal Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double tract anatomosisProcedure or surgery
After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers.
EsophagogastrostomyProcedure or surgery
After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler.
| Study group | Role | What they receive |
|---|---|---|
| Double tract anatomosis | Experimental | After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers. Receives: Procedure: Double tract anatomosis |
| Esophagogastrostomy | Active comparator | After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler. Receives: Procedure: Esophagogastrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reflux esophagitis after operation
The rate of reflux esophagitis after operation will be assessed by gastrointestinal endoscopy with Los Angeles (LA) classification. the degree of reflux esophagitis will be classified as N, A, B, C or D level, and latter levels represent a more severe reflux esophagitis.
Measured: 12 months
Secondary outcomes (2)
postoperative quality of life
Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - C30 questionnaire, the total score ranges from 30 to 126, and higher values represent a worse outcome.
Measured: 12months
postoperative quality of life
Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - STO22 questionnaire, the total score ranges from 22 to 88, and higher values represent a worse outcome.
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Jan 2019 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biao Fan, MD, Peking University Cancer Hospital & Institute
- Investigators
- Xin Ji, M.D., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613142
- Sponsor's protocol ID
- DTvsEG
- Status last verified
- Nov 2018
- First submitted
- 23 Jul 2018
- Last updated
- 8 Nov 2018
- 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 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy: A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03613142
- Acronym / sponsor ID
- DTvsEG
- Conditions
- Gastric Cancer, GastroEsophageal Cancer
- Keywords
- Double tract, Esophagogastrostomy, Gastric cancer, GastroEsophageal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 2 Aug 2018 (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.
The patients with upper gastric cancer (cT1N0M0) or gastroesophageal adenocarcinoma (diameter less than 4 cm) will be enrolled into this study. Each of these patients will undergo radical proximal gastrectomy and be randomly allocated into one of the two groups, double tract anastomosis group or esophagogastrostomy group. The following data will be collected to compare the difference between the two reconstruction methods: the rate of reflux esophagitis, postoperative quality of life, economic expenditure, the safety of operation, postoperative recovery, postoperative nutrition status and oncological effect. Through the comprehensive analysis, the result of this study will elucidate the best of the reconstruction method after proximal gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double tract anatomosis | Experimental | Procedure: Double tract anatomosisAfter the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers. |
| Esophagogastrostomy | Active comparator | Procedure: EsophagogastrostomyAfter the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed as gastric or esophagogastric adenocarcinoma
- Age ranges from 18 to 80
- Karnofsky assessment no less than 70
- Completion of abdominal CT scan and ultrasound endoscopy
- Upper gastric cancer (cT1N0M0) or esophagogastric adenocarcinoma (diameter no more than 4 cm)
Key exclusion criteria (4 listed)
- Patients need to undergo total gastrectomy or distal gastrectomy
- Female patients with pregnancy
- Not suitable for operation
- Patients have already joined other clinical trials
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 |
|---|---|---|
| Double tract anatomosisAfter the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers. | Procedure or surgery | Double tract anatomosis |
| EsophagogastrostomyAfter the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler. | Procedure or surgery | Esophagogastrostomy |
Primary outcome
Rate of reflux esophagitis after operation
Time frame: 12 months
The rate of reflux esophagitis after operation will be assessed by gastrointestinal endoscopy with Los Angeles (LA) classification. the degree of reflux esophagitis will be classified as N, A, B, C or D level, and latter levels represent a more severe reflux esophagitis.
2 secondary outcomes
postoperative quality of life
Time frame: 12months
postoperative quality of life
Time frame: 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- 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.
Xin Ji, M.D. principal investigator
Peking University Cancer Hospital & Institute
Questions about this trial
What is this clinical trial studying?
A study testing Double tract anatomosis and Esophagogastrostomy in people with Gastric Cancer and GastroEsophageal Cancer, run by Peking University Cancer Hospital & Institute.
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 7 inclusion and 4 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 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Xin Ji, M.D. (+86 18601201053, 18601201053@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of reflux esophagitis after operation (time frame: 12 months). 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 8 Nov 2018.