Gastric CancerPhase 2NCT02694081
The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric
A Phase 2 study testing Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction in people with Gastric Cancer, run by Jilin University at 1 site in China.
Trial summary
The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Feb 2017
- Phase
- Phase 2
- 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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of distal gastric cancer
- underwent laparoscopy-assisted distal gastrectomy
Who cannot join
- have simultaneously other cancer
- have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
- have upper gastrointestinal surgery
- can't bear the gastric tube
- the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first hospital of Jilin University
Changchun, Jilin, 130021
Dong Yang, master, 714488468@qq.com
Quan Wang, proffessor, 18844097668@163.com
About this study
Official title: The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction
The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric.
Read the detailed description
To search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between Uncut Roux-en-Y and Billroth II reconstructions after laparoscopy-assisted distal gastrectomy for gastric cancer.
Method: It's a prospective study including all patients underwent laparoscopy-assisted distal gastrectomy (LADG) in the First Hospital of Jilin University, from February 2016 to February 2017. All surgical procedures will be performed by the single surgery team, which is leaded by professor Wang Quan. The reconstruction method will be selected randomly from Uncut Roux-en-Y and Billroth II anastomosis by drawing lots preoperatively without distinct indications. Clinical data, operation data and perioperative complications and related physiological indexes of differences.
- Conditions
- Gastric Cancer
- Being tested
- Uncut Roux-en-Y Reconstruction, Billroth II Reconstruction
- Keywords
- reflux, residue, Gastric stasis, Emptying time
- Medical subject headings
- Stomach Neoplasms, Gastroesophageal Reflux, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncut Roux-en-Y ReconstructionProcedure or surgery
All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group.
Billroth II ReconstructionProcedure or surgery
All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group.
| Study group | Role | What they receive |
|---|---|---|
| Uncut Roux-en-Y Reconstruction | Experimental | Uncut Roux-en-Y Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer. Receives: Procedure: Uncut Roux-en-Y Reconstruction |
| Billroth II Reconstruction | Active comparator | Billroth II Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer. Receives: Procedure: Billroth II Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
The time of reconstruction operation will be recorded in the operating note by nurses in minutes.
Measured: within 2 hours after surgery
change of potential of hydrogen ( pH) in remnant stomach
In the morning of 1-6 days after operation , monitor the number of gastric juice's potential of hydrogen ( pH) value through gastric tube and write down the data. So if the data is greater than 7,the complication of bile reflux happened
Measured: 1-6 days after surgery
the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
During the operation the amount of blood loss will be recorded in the operating note by nurses in milliliters.
Measured: within 2 hours after surgery
Secondary outcomes (2)
the number of patients with the complication of Residual food
During the upper gastrointestinal radiography，if there is residual food,the meglumine diatrizoate will be separate and then write down the number.
Measured: 6 month after surgery
the number of patients with the complication of Reflux esophagitis
During the upper gastrointestinal radiography,if there is meglumine diatrizoate refluxing to esophagus,it will be observed and written down in number.
Measured: 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiping shi, Jilin University
- Investigators
- Quan Wang, professor, Study director, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694081
- Sponsor's protocol ID
- 130021
- Other IDs
- 714488468
- Status last verified
- Jul 2016
- First submitted
- 29 Jan 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cai Z, Mu M, Ma Q, Liu C, Jiang Z, Liu B, Ji G, Zhang B. Uncut Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2024 Feb 29;2(2):CD015014. doi: 10.1002/14651858.CD015014.pub2.
PubMed 38421211
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction
- ClinicalTrials.gov ID
- NCT02694081
- Acronym / sponsor ID
- 130021
- Conditions
- Gastric Cancer
- Keywords
- reflux, residue, Gastric stasis, Emptying time
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 29 Feb 2016 (estimated)
- 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 Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric.
Detailed description
To search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between Uncut Roux-en-Y and Billroth II reconstructions after laparoscopy-assisted distal gastrectomy for gastric cancer.
Method: It's a prospective study including all patients underwent laparoscopy-assisted distal gastrectomy (LADG) in the First Hospital of Jilin University, from February 2016 to February 2017. All surgical procedures will be performed by the single surgery team, which is leaded by professor Wang Quan. The reconstruction method will be selected randomly from Uncut Roux-en-Y and Billroth II anastomosis by drawing lots preoperatively without distinct indications. Clinical data, operation data and perioperative complications and related physiological indexes of differences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uncut Roux-en-Y Reconstruction | Experimental | Procedure: Uncut Roux-en-Y ReconstructionUncut Roux-en-Y Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer. |
| Billroth II Reconstruction | Active comparator | Procedure: Billroth II ReconstructionBillroth II Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer. |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of distal gastric cancer
- underwent laparoscopy-assisted distal gastrectomy
Key exclusion criteria (5 listed)
- have simultaneously other cancer
- have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
- have upper gastrointestinal surgery
- can't bear the gastric tube
- the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy
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 |
|---|---|---|
| Uncut Roux-en-Y ReconstructionAll surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group. | Procedure or surgery | Uncut Roux-en-Y Reconstruction |
| Billroth II ReconstructionAll surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group. | Procedure or surgery | Billroth II Reconstruction |
Primary outcome
The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
Time frame: within 2 hours after surgery
The time of reconstruction operation will be recorded in the operating note by nurses in minutes.
change of potential of hydrogen ( pH) in remnant stomach
Time frame: 1-6 days after surgery
In the morning of 1-6 days after operation , monitor the number of gastric juice's potential of hydrogen ( pH) value through gastric tube and write down the data. So if the data is greater than 7,the complication of bile reflux happened
the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction
Time frame: within 2 hours after surgery
During the operation the amount of blood loss will be recorded in the operating note by nurses in milliliters.
2 secondary outcomes
the number of patients with the complication of Residual food
Time frame: 6 month after surgery
the number of patients with the complication of Reflux esophagitis
Time frame: 6 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Derived from this study: PubMed 38421211Cai Z, Mu M, Ma Q, Liu C, Jiang Z, Liu B, Ji G, Zhang B. Uncut Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2024 Feb 29;2(2):CD015014. doi: 10.1002/14651858.CD015014.pub2.
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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.
Quan Wang, professor study director
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction in people with Gastric Cancer, run by Jilin University at 1 site in China.
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 2 inclusion and 5 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 2 Jan 2017. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dong Yang, postgraduate (18243052038, 714488468@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction (time frame: within 2 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694081, which also lists 1 linked publication.
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 2 Jan 2017.