Gastric CancerTLDGNCT02372747
Comparison of Delta-Shaped and Billroth II After TLDG
A study testing Delta-shaped anastomosis and Billroth II anastomosis in people with Gastric Cancer, run by The First Hospital of Jilin University.
Trial summary
To compare the safety and feasibility of Delta-shaped anastomosis and Billroth II anastomosis after totally laparoscopic distal gastrectomy for gastric cancer(TLDG). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Delta-shaped anastomosis and Billroth II anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- carcinoma located in the lower 1/3 of gastric body or antrum of stomach
- diagnosed by endoscopy ,endoscopic ultrasonography and abdominal CT scan
- diameter of the tumor <3cm
- no pyloric obstruction
Who cannot join
- diameter of the tumor ≥3cm
- associated with obstruction, bleeding, emergency surgery or surgical intervention
- tumor with extensive metastasis
- patient had previously undergone gastrostomy
About this study
Official title: Comparison of Delta-Shaped and Billroth II for Intracorporeal Anastomosis After Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
To compare the safety and feasibility of Delta-shaped anastomosis and Billroth II anastomosis after totally laparoscopic distal gastrectomy for gastric cancer(TLDG).
Read the detailed description
Methods: 78 consecutive patients who underwent TLDG in First Hospital of Jilin University between October 2012 and December 2014 were enrolled in this study . All patients were divided randomly into two groups:Delta-shaped anastomosis group (DS group) and Billroth II anastomosis group (B-II group), and the patients in DS group underwent Delta-shaped anastomosis after TLDG, and the patients in B-II group underwent Billroth-II anastomosis after TLDG.Outcome measures,resected margin,operative time,anastomosis time,number of stapler cartridges used,length of the incision,the time of first flatus and liquid diet,hospital stay and postoperative morbidity are compared between the two groups.
- Conditions
- Gastric Cancer
- Being tested
- Delta-shaped anastomosis, Billroth II anastomosis
- Keywords
- Totally laparoscopic gastrectomy, laparoscopic distal gastrectomy, Intracorporeal anastomosis, Delta-Shaped Anastomosis, Billroth II Anastomosis, Gastric 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.
Delta-shaped anastomosisProcedure or surgery
The patients in DS group underwent Delta-shaped anastomosis after TLDG.
Billroth II anastomosisProcedure or surgery
The patients in B-II group underwent Billroth-II anastomosis after TLDG.
| Study group | Role | What they receive |
|---|---|---|
| Delta-shaped anastomosis group | Experimental | The patients in DS group underwent Delta-shaped anastomosis after TLDG. Receives: Procedure: Delta-shaped anastomosis |
| Billroth II anastomosis group | Experimental | The patients in B-II group underwent Billroth-II anastomosis after TLDG. Receives: Procedure: Billroth II anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage distribution
Measured: up to 7 days after the operation
Resected margin
Measured: up to 7 days after the operation
Operative time
Measured: up to 7 days after the operation
Anastomosis time
Measured: up to 7 days after the operation
The number of stapler cartridges used
Measured: up to 7 days after the operation
Median estimated blood loss
Measured: up to 7 days after the operation
Red blood cell transfusion
Measured: up to 7 days after the operation
Length of the incision
Measured: up to 7 days after the operation
Secondary outcomes (1)
Postoperative complication
Major complications includes anastomosis leakage and intrabdominal bleeding . Minor complications includes bile regurgitation,anastomotic stenosis and delayed gastric emptying.
Measured: up to 30 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionDec 2014
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 The First Hospital of Jilin UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Wang, The First Hospital of Jilin University
- Investigators
- Quan Wang, Doctor, Study director, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372747
- Sponsor's protocol ID
- 2013-179
- Acronym
- TLDG
- Status last verified
- Feb 2006
- First submitted
- 22 Jan 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Delta-Shaped and Billroth II for Intracorporeal Anastomosis After Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT02372747
- Acronym / sponsor ID
- TLDG / 2013-179
- Conditions
- Gastric Cancer
- Keywords
- Totally laparoscopic gastrectomy, laparoscopic distal gastrectomy, Intracorporeal anastomosis, Delta-Shaped Anastomosis, Billroth II Anastomosis, Gastric cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Feb 2015 (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.
To compare the safety and feasibility of Delta-shaped anastomosis and Billroth II anastomosis after totally laparoscopic distal gastrectomy for gastric cancer(TLDG).
Detailed description
Methods: 78 consecutive patients who underwent TLDG in First Hospital of Jilin University between October 2012 and December 2014 were enrolled in this study . All patients were divided randomly into two groups:Delta-shaped anastomosis group (DS group) and Billroth II anastomosis group (B-II group), and the patients in DS group underwent Delta-shaped anastomosis after TLDG, and the patients in B-II group underwent Billroth-II anastomosis after TLDG.Outcome measures,resected margin,operative time,anastomosis time,number of stapler cartridges used,length of the incision,the time of first flatus and liquid diet,hospital stay and postoperative morbidity are compared between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delta-shaped anastomosis group | Experimental | Procedure: Delta-shaped anastomosisThe patients in DS group underwent Delta-shaped anastomosis after TLDG. |
| Billroth II anastomosis group | Experimental | Procedure: Billroth II anastomosisThe patients in B-II group underwent Billroth-II anastomosis after TLDG. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- carcinoma located in the lower 1/3 of gastric body or antrum of stomach
- diagnosed by endoscopy ,endoscopic ultrasonography and abdominal CT scan
- diameter of the tumor <3cm
- no pyloric obstruction
Key exclusion criteria (4 listed)
- diameter of the tumor ≥3cm
- associated with obstruction, bleeding, emergency surgery or surgical intervention
- tumor with extensive metastasis
- patient had previously undergone gastrostomy
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 |
|---|---|---|
| Delta-shaped anastomosisThe patients in DS group underwent Delta-shaped anastomosis after TLDG. | Procedure or surgery | Delta-shaped anastomosis group |
| Billroth II anastomosisThe patients in B-II group underwent Billroth-II anastomosis after TLDG. | Procedure or surgery | Billroth II anastomosis group |
Primary outcome
Stage distribution
Time frame: up to 7 days after the operation
Resected margin
Time frame: up to 7 days after the operation
Operative time
Time frame: up to 7 days after the operation
Anastomosis time
Time frame: up to 7 days after the operation
The number of stapler cartridges used
Time frame: up to 7 days after the operation
Median estimated blood loss
Time frame: up to 7 days after the operation
Red blood cell transfusion
Time frame: up to 7 days after the operation
Length of the incision
Time frame: up to 7 days after the operation
1 secondary outcome
Postoperative complication
Time frame: up to 30 days after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
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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, Doctor study director
The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
A study testing Delta-shaped anastomosis and Billroth II anastomosis in people with Gastric Cancer, run by The First Hospital of Jilin University.
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 4 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: finished, as of the sponsor's last update on 26 Feb 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage distribution (time frame: up to 7 days after the operation). 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 26 Feb 2015.