GastrectomyPhase 3NCT01142271
Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy
A Phase 3 study testing Billroth-I and Roux en Y in people with Gastrectomy, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastrectomy
- What is being tested?
- Billroth-I and Roux en Y
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to May 2012
- Phase
- Phase 3
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with adenocarcinoma at the endoscopic biopsy
- Patients who are possible to be performed curative resection in imaging study
- Patients with tumor which not involved in pylorus and are located in mid or distal portion of the stomach
- Patients with informed consent
- Patients with three or less American Society Anesthesiology Score 3
Who cannot join
- Patients who are or become pregnant
- Patients with uncontrolled disease
- Patient s with synchronous other malignancy
- Patients participated in other clinical trial
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou University Hospital
Suwon, 422-749
Hoon Hur, M.D., +82-31-219-5207, hhcmc75@naver.com
Jun Young Kim, M.D., +82-31-219-5206, murmur2@hanmail.net
About this study
Official title: Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy for Gastric Cancer Patients : Prospective Randomized Study
The purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer
Read the detailed description
Most common procedure for the resection of gastric cancers located in middle or lower stomach is distal subtotal gastrectomy. However, the optimal reconstruction procedure after that has still not to be established. Although B-I reconstruction is most common method due to the safety and simplicity, the duodenal fluid may reflux into the remnant stomach which may contribute to the mucosal injury to remnant stomach and esophagus. Roux en Y reconstruction may reduce the reflux to remnant stomach due to the length of Roux en Y limb, although it is more complicated procedure.
Therefore, we plan to collect 120 patients to compare the degree of reflux between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer. In addition, we compare the surgical outcome and quality of life between two groups.
- Conditions
- Gastrectomy
- Being tested
- Billroth-I, Roux en Y
- Keywords
- Distal gastrectomy, Reconstruction, Reflux, subtotal gastrectomy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Billroth-IProcedure or surgery
Also called Gastroduodenostomy
Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, gastroduodenostomy should be performed by circular stapler. In addition, stapler sites were re-enforced.
Roux en YProcedure or surgery
Also called Gastrojejunostomy and jejunojejunostomy
Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, jejunojejunostomy and gastrojejunostomy should be performed by circular staplers. In addition, stapler sites were re-enforced.
| Study group | Role | What they receive |
|---|---|---|
| Billroth-I | Experimental | Patients in this group should be underwent gastroduodenostomy as reconstruction procedure after standard distal subtotal gastrectomy with lymph node dissection. Receives: Procedure: Billroth-I |
| Roux en Y | Experimental | Patients in this group should be underwent jejunojejunostomy and gastrojejunostomy as reconstruction procedure after standard distal gastrectomy. Receives: Procedure: Roux en Y |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflux of bile content
We estimate the degree of reflux by gastrofiberscopic findings using reflux score suggested by Romaganoli. In addition, histological finding of remnant stomach by endoscopic biopsy is also investigated. Reflux symptom is surveyed by Gastrointestinal Symptom Rating Scale.
Measured: 6 months after surgery
Secondary outcomes (6)
Quality of Life
We investigate the quality of life with EORTC-C30, EORTC-STO22 questionnaire suggested by European Organization for Research and Treatment of Cancer (EORTC).
Measured: 6 months after surgery
Morbidity
We investigate the occurrence of complication during recovery after surgery.
Measured: 2 month after surgery
Anastomotic time
We estimate anastomosis time
Measured: Day 1
Nutritional state
We estimate Albumin, transferrin, lymphocyte, body weight
Measured: 6 month after surgery
Mortality
We investigate the occurrence of operation-related death during recovery after surgery.
Measured: 2 month after operation
Operation time
We estimate total operation time.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GastrectomyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Uk Han, Ajou University School of Medicine
- Investigators
- Sang-Uk Han, M.D., Ph D., Principal investigator, Department of Surgery, Ajou University School of MedicineHoon Hur, M.D., Study director, Department of Surgery, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142271
- Sponsor's protocol ID
- AJIRB-MED-DEO-09-297
- Status last verified
- Nov 2011
- First submitted
- 8 Jun 2010
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Chan DC, Fan YM, Lin CK, Chen CJ, Chen CY, Chao YC. Roux-en-Y reconstruction after distal gastrectomy to reduce enterogastric reflux and Helicobacter pylori infection. J Gastrointest Surg. 2007 Dec;11(12):1732-40. doi: 10.1007/s11605-007-0302-0. Epub 2007 Sep 18.
PubMed 17876675Ishikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma. World J Surg. 2005 Nov;29(11):1415-20; discussion 1421. doi: 10.1007/s00268-005-7830-0.
PubMed 16240061Nishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2.
PubMed 34523717Hur H, Ahn CW, Byun CS, Shin HJ, Kim YB, Son SY, Han SU. A Novel Roux-en-Y Reconstruction Involving the Use of Two Circular Staplers after Distal Subtotal Gastrectomy for Gastric Cancer. J Gastric Cancer. 2017 Sep;17(3):255-266. doi: 10.5230/jgc.2017.17.e32. Epub 2017 Sep 26.
PubMed 28970956
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy for Gastric Cancer Patients : Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01142271
- Acronym / sponsor ID
- AJIRB-MED-DEO-09-297
- Conditions
- Gastrectomy
- Keywords
- Distal gastrectomy, Reconstruction, Reflux, subtotal gastrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 11 Jun 2010 (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 purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer
Detailed description
Most common procedure for the resection of gastric cancers located in middle or lower stomach is distal subtotal gastrectomy. However, the optimal reconstruction procedure after that has still not to be established. Although B-I reconstruction is most common method due to the safety and simplicity, the duodenal fluid may reflux into the remnant stomach which may contribute to the mucosal injury to remnant stomach and esophagus. Roux en Y reconstruction may reduce the reflux to remnant stomach due to the length of Roux en Y limb, although it is more complicated procedure.
Therefore, we plan to collect 120 patients to compare the degree of reflux between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer. In addition, we compare the surgical outcome and quality of life between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Billroth-I | Experimental | Procedure: Billroth-IPatients in this group should be underwent gastroduodenostomy as reconstruction procedure after standard distal subtotal gastrectomy with lymph node dissection. |
| Roux en Y | Experimental | Procedure: Roux en YPatients in this group should be underwent jejunojejunostomy and gastrojejunostomy as reconstruction procedure after standard distal gastrectomy. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with adenocarcinoma at the endoscopic biopsy
- Patients who are possible to be performed curative resection in imaging study
- Patients with tumor which not involved in pylorus and are located in mid or distal portion of the stomach
- Patients with informed consent
- Patients with three or less American Society Anesthesiology Score 3
Key exclusion criteria (4 listed)
- Patients who are or become pregnant
- Patients with uncontrolled disease
- Patient s with synchronous other malignancy
- Patients participated in other clinical trial
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 |
|---|---|---|
| Billroth-IAlso: GastroduodenostomyStandard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, gastroduodenostomy should be performed by circular stapler. In addition, stapler sites were re-enforced. | Procedure or surgery | Billroth-I |
| Roux en YAlso: Gastrojejunostomy and jejunojejunostomyStandard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, jejunojejunostomy and gastrojejunostomy should be performed by circular staplers. In addition, stapler sites were re-enforced. | Procedure or surgery | Roux en Y |
Primary outcome
Reflux of bile content
Time frame: 6 months after surgery
We estimate the degree of reflux by gastrofiberscopic findings using reflux score suggested by Romaganoli. In addition, histological finding of remnant stomach by endoscopic biopsy is also investigated. Reflux symptom is surveyed by Gastrointestinal Symptom Rating Scale.
6 secondary outcomes
Quality of Life
Time frame: 6 months after surgery
Morbidity
Time frame: 2 month after surgery
Anastomotic time
Time frame: Day 1
Nutritional state
Time frame: 6 month after surgery
Mortality
Time frame: 2 month after operation
Operation time
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
- Background: PubMed 17876675Chan DC, Fan YM, Lin CK, Chen CJ, Chen CY, Chao YC. Roux-en-Y reconstruction after distal gastrectomy to reduce enterogastric reflux and Helicobacter pylori infection. J Gastrointest Surg. 2007 Dec;11(12):1732-40. doi: 10.1007/s11605-007-0302-0. Epub 2007 Sep 18.
- Background: PubMed 16240061Ishikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma. World J Surg. 2005 Nov;29(11):1415-20; discussion 1421. doi: 10.1007/s00268-005-7830-0.
- Derived from this study: PubMed 34523717Nishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2.
- Derived from this study: PubMed 28970956Hur H, Ahn CW, Byun CS, Shin HJ, Kim YB, Son SY, Han SU. A Novel Roux-en-Y Reconstruction Involving the Use of Two Circular Staplers after Distal Subtotal Gastrectomy for Gastric Cancer. J Gastric Cancer. 2017 Sep;17(3):255-266. doi: 10.5230/jgc.2017.17.e32. Epub 2017 Sep 26.
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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.
Sang-Uk Han, M.D., Ph D. principal investigator
Department of Surgery, Ajou University School of Medicine
Hoon Hur, M.D. study director
Department of Surgery, Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Billroth-I and Roux en Y in people with Gastrectomy, run by Ajou University School of Medicine at 1 site in South Korea.
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 5 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 7 Nov 2011. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Hoon Hur, M.D. (+82-31-219-2507, hhcmc75@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux of bile content (time frame: 6 months after surgery). 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 NCT01142271, which also lists 4 linked publications.
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 7 Nov 2011.