Stomach CancerPhase 3NCT00622804
Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy
A Phase 3 study testing Billroth-II (B-II), Roux en Y gastrojejunostomy (RY-GJ) and uncut Roux en Y gastrojejunostomy in people with Stomach Cancer and Gastrectomy, run by The Catholic University of Korea at 5 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Stomach Cancer, Gastrectomy
- What is being tested?
- Billroth-II (B-II), Roux en Y gastrojejunostomy (RY-GJ) and uncut Roux en Y gastrojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Jul 2007to Jul 2009
- 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 who underwent distal gastrectomy for adenocarcinoma of stomach with following criteria:
- have cancer located in middle or distal portions
- preoperative staged as cT1N0M0 or cT2N0M0 by computed tomography and gastrofiberscope (Endoscopic ultrasound, optionally)
- have The American Society of Anaesthesiologists (ASA) score of three and less
Who cannot join
- Patients following criteria:
- have simultaneously other cancer
- underwent cancer therapy (radiologic or immunologic or chemotherapeutic method) at past time
- have systemic inflammatory disease
- have upper gastrointestinal surgery
- have the gastric cancer with obstruction
Show all 11Show fewer
- get pregnancy
- are treating diabetics with Insulin
- are participating or participated within 1 month in other clinical trials
- have BMI less than 25
- are expected to perform laparoscopy assisted gastrectomy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Department of Surgery, Holy Family Hospital, The Catholic University of Korea
Bucheon-si, 420-717
Department of Surgery, Our Lady of Mercy Hospital, The Catholic University of Korea
Incheon, 403-720
Department of Surgery, Kangnam St. Mary's Hospital, The Catholic University of Korea
Seoul, 137-710
Department of Surgery, St Mary's Hospital, The Catholic University of Korea
Seoul, 150-713
Department of Surgery, St. Vincent's Hopital, The Catholic University of Korea
Suwon, 442-723
About this study
Official title: Phase III Study on Comparison for Bile Reflux and Gastric Stasis in Patients With Gastric Cancer After Distal Gastrectomy
The purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method. We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).
Read the detailed description
Patients who have undergone gastrectomy for gastric cancer might be developed various symptoms by gastric stasis and bile reflux, it so called "post-gastrectomy syndrome", because of the diminishment of stomach capacity, the decrease of expulsive ability and the change of food passage. Until now, that had been accepted as the inevitable results after gastric resection. However, the survival rate has recently been increased owing to the increased proportion of early gastric cancer. And thus, to improve the quality of life of patients, many researchers have been actually studying for the reconstruction methods which are able to minimize the symptom by gastrectomy, but it is dissatisfied until now. Thus, the purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method.
We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ). We evaluate the postoperative morbidity rate and then the degree of bile reflux, gastric emptying time and quality of life through long term follow-up using the gastrofiberscope, survey and so on.
From this study, we would suggest the standard reconstruction procedure after distal gastrectomy.
- Conditions
- Stomach Cancer, Gastrectomy
- Being tested
- Billroth-II (B-II), Roux en Y gastrojejunostomy (RY-GJ), uncut Roux en Y gastrojejunostomy
- Keywords
- Stomach cancer, Gastrectomy, Postgastrectomy syndrome
- Medical subject headings
- Stomach Neoplasms, Postgastrectomy Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Billroth-II (B-II)Procedure or surgery
Also called B-II
After conventional distal gastrectomy with lymphadenectomy, jejunum of a distal segment from 10 to 20cm from Treitz is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done.
Roux en Y gastrojejunostomy (RY-GJ)Procedure or surgery
Also called RY-GJ
After conventional distal gastrectomy with lymphadenectomy, jejunum is transected in the segment from 10 to 20 cm, and then distal end is transposed in a way of retro-colon to perform anastomosis using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done. The resected proximal jejunum and the portion of jejunum distal 45 cm from gastrojejunostomy are anastomosed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture.
uncut Roux en Y gastrojejunostomyProcedure or surgery
Also called uncut RY-GJ
After conventional distal gastrectomy with lymphadenectomy, jejunum of distal segment 45 cm from Treitz ligament is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture. After anastomosis, afferent loop distal 5cm is obstructed using non-cutting stapler or hand sawing suture. And then, distal jejunum 10 cm from obstructive portion and efferent jejunal loop distal 45 cm from gastrojejunostomy are anastomosed in a manner of side to side followed by reinforcement suture.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Billroth-II (B-II)reconstruction Receives: Procedure: Billroth-II (B-II) |
| 2 | Other | Roux en Y gastrojejunostomy (RY-GJ) Receives: Procedure: Roux en Y gastrojejunostomy (RY-GJ) |
| 3 | Other | uncut Roux en Y gastrojejunostomy (uncut RY-GJ) Receives: Procedure: uncut Roux en Y gastrojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bile reflux by Dual scintigraphy
Measured: six month and one year after operation
Secondary outcomes (4)
Gastric emptying time by Dual scintigraphy
Measured: six month and one year after operation
Residual food, gastritis, bile reflux and reflux esophagitis by Gastrofiberscope findings
Measured: six month and one year after operation
Quality of life by EORTC QLQ30, STO22
Measured: one year after operation
Morbidity and Mortality
Measured: In hosipital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionJul 2009 (estimated)
Why it stopped: It was very difficult to enroll patients in this study.
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 Stomach 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Investigators
- Wook Kim, MD, PhD, Principal investigator, Department of Surgery, Holy Family Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622804
- Sponsor's protocol ID
- HCHC06OT049
- Status last verified
- Jul 2009
- First submitted
- 14 Feb 2008
- Last updated
- 3 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ogoshi K, Okamoto Y, Nabeshima K, Morita M, Nakamura K, Iwata K, Soeda J, Kondoh Y, Makuuchi H. Focus on the conditions of resection and reconstruction in gastric cancer. What extent of resection and what kind of reconstruction provide the best outcomes for gastric cancer patients? Digestion. 2005;71(4):213-24. doi: 10.1159/000087046. Epub 2004 Sep 6.
PubMed 16024924
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study on Comparison for Bile Reflux and Gastric Stasis in Patients With Gastric Cancer After Distal Gastrectomy
- ClinicalTrials.gov ID
- NCT00622804
- Acronym / sponsor ID
- HCHC06OT049
- Conditions
- Stomach Cancer, Gastrectomy
- Keywords
- Stomach cancer, Gastrectomy, Postgastrectomy syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was very difficult to enroll patients in this study.
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2009 (estimated)
- First posted
- 25 Feb 2008 (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 study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method. We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).
Detailed description
Patients who have undergone gastrectomy for gastric cancer might be developed various symptoms by gastric stasis and bile reflux, it so called "post-gastrectomy syndrome", because of the diminishment of stomach capacity, the decrease of expulsive ability and the change of food passage. Until now, that had been accepted as the inevitable results after gastric resection. However, the survival rate has recently been increased owing to the increased proportion of early gastric cancer. And thus, to improve the quality of life of patients, many researchers have been actually studying for the reconstruction methods which are able to minimize the symptom by gastrectomy, but it is dissatisfied until now. Thus, the purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method.
We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ). We evaluate the postoperative morbidity rate and then the degree of bile reflux, gastric emptying time and quality of life through long term follow-up using the gastrofiberscope, survey and so on.
From this study, we would suggest the standard reconstruction procedure after distal gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Billroth-II (B-II)Billroth-II (B-II)reconstruction |
| 2 | Other | Procedure: Roux en Y gastrojejunostomy (RY-GJ)Roux en Y gastrojejunostomy (RY-GJ) |
| 3 | Other | Procedure: uncut Roux en Y gastrojejunostomyuncut Roux en Y gastrojejunostomy (uncut RY-GJ) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who underwent distal gastrectomy for adenocarcinoma of stomach with following criteria:
Key exclusion criteria (11 listed)
- Patients following criteria:
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-II (B-II)Also: B-IIAfter conventional distal gastrectomy with lymphadenectomy, jejunum of a distal segment from 10 to 20cm from Treitz is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done. | Procedure or surgery | 1 |
| Roux en Y gastrojejunostomy (RY-GJ)Also: RY-GJAfter conventional distal gastrectomy with lymphadenectomy, jejunum is transected in the segment from 10 to 20 cm, and then distal end is transposed in a way of retro-colon to perform anastomosis using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done. The resected proximal jejunum and the portion of jejunum distal 45 cm from gastrojejunostomy are anastomosed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture. | Procedure or surgery | 2 |
| uncut Roux en Y gastrojejunostomyAlso: uncut RY-GJAfter conventional distal gastrectomy with lymphadenectomy, jejunum of distal segment 45 cm from Treitz ligament is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture. After anastomosis, afferent loop distal 5cm is obstructed using non-cutting stapler or hand sawing suture. And then, distal jejunum 10 cm from obstructive portion and efferent jejunal loop distal 45 cm from gastrojejunostomy are anastomosed in a manner of side to side followed by reinforcement suture. | Procedure or surgery | 3 |
Primary outcome
Bile reflux by Dual scintigraphy
Time frame: six month and one year after operation
4 secondary outcomes
Gastric emptying time by Dual scintigraphy
Time frame: six month and one year after operation
Residual food, gastritis, bile reflux and reflux esophagitis by Gastrofiberscope findings
Time frame: six month and one year after operation
Quality of life by EORTC QLQ30, STO22
Time frame: one year after operation
Morbidity and Mortality
Time frame: In hosipital
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2009.
- Background: PubMed 16024924Ogoshi K, Okamoto Y, Nabeshima K, Morita M, Nakamura K, Iwata K, Soeda J, Kondoh Y, Makuuchi H. Focus on the conditions of resection and reconstruction in gastric cancer. What extent of resection and what kind of reconstruction provide the best outcomes for gastric cancer patients? Digestion. 2005;71(4):213-24. doi: 10.1159/000087046. Epub 2004 Sep 6.
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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.
Wook Kim, MD, PhD principal investigator
Department of Surgery, Holy Family Hospital, The Catholic University of Korea
5 sites 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-II (B-II), Roux en Y gastrojejunostomy (RY-GJ) and uncut Roux en Y gastrojejunostomy in people with Stomach Cancer and Gastrectomy, run by The Catholic University of Korea at 5 sites 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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 3 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Bile reflux by Dual scintigraphy (time frame: six month and one year after operation). 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 NCT00622804, 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 3 Aug 2009.