Stomach NeoplasmPhase 1NCT00741676
Comparison of the Laparoscopy-Assisted Distal Gastrectomy and Open Distal Gastrectomy for Advanced Gastric Cancer
A Phase 1 study testing laparoscopy-assisted distal gastrectomy and open distal gastrectomy in people with Stomach Neoplasm, run by The Catholic University of Korea at 2 sites in South Korea.
Trial summary
Among surgical methods for gastric cancer, incision about 15 ~20 cm length is prepared for open gastric cancer surgery while 0.5 ~ 1.2 cm is for laparoscopy gastric cancer surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stomach Neoplasm
- What is being tested?
- laparoscopy-assisted distal gastrectomy and open distal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Aug 2008to Jul 2013
- Phase
- Phase 1
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma
- Age: older than 20 year old, younger than 80 year old
- Cancer core: located at the middle or lower part of stomach
- Preoperative cancer stage (CT, GFS stage): cT2N0M0, cT2aN1M0, cT2bN1M0, cT3N0M0
- ASA score: ≤ 3
- Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)
Who cannot join
- Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
- Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
- Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
- Patient who was treated because of systemic inflammatory disease
- Pregnant patient
- Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 1 recruiting
- Recruiting
Department of Surgery, Holy Family Hospital, The Catholic University of Korea
Bucheon-si, Gyunggi Do, 420-717
Wook Kim, Professor, +82-340-7022, kimwook@catholic.ac.kr
Junhyun Lee, Instructor, +82-340-7026, surgeryjun@catholic.ac.kr
- Active, not recruiting
Department of Surgery, Holy Family Hospital. College of Medicine. The Catholic University of Korea
Pucheon, Gyeonggi-do, 420-717
About this study
Official title: Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy (ODG) for Advanced Gastric Cancer (Stage Ib and II).
Among surgical methods for gastric cancer, incision about 15 ~20 cm length is prepared for open gastric cancer surgery while 0.5 ~ 1.2 cm is for laparoscopy gastric cancer surgery. Complications such as pain, abdominal adhesion, and problems associated with delayed recovery are common in open surgery because of large incision; however, those complications are less common in laparoscopy surgery because small sized incision is prepared. Range of surgery for curative dissection depends on the level of progress of a cancer, i.e., depends on whether gastric wall invasion, lymph node metastasis, or invasion to adjacent organs presented. Since recurrence in the lymph nodes after the operation is very common, the most important step in the gastric surgery is to dissect lymph node completely. According to the gastric cancer surgery manual published by Japan Gastric Cancer Association, more than D2 lymph node dissection is essential for improving survival rate in advanced gastric cancer. More than D2 lymph node dissection is relatively safely conducted by open surgery, whereas it is controversial in laparoscopy surgery because it is very hard to maintain surgical field under laparoscopic condition. Recently, widened rage of lymph node dissection by using laparoscopy is possible as laparoscopic surgical techniques are accumulated and new surgical devices are introduced. According to the case reports, D2 lymph node dissection by laparoscopy surgery shows similar results to the one by open surgery in aspects of recurrence rate and the number of dissected lymph node. Also, according to Hur and el., in case of upper gastric cancer, laparoscopy surgery is more useful to dissect #10 and #11 lymph node.In our prospective case study, the investigators would like to compare effectiveness, complications, patterns of recurrence, and survival rate between the two surgical approaches, laparoscopy distal gastrectomy and open distal gastrectomy. The investigators randomly operate the advanced gastric cancer patients, who need distal gastrectomy and D2 lymph node dissection. Surgical methods are selected randomly whether open surgery or laparoscopy surgery. Finally, the investigators wish our case report to contribute to the establishment of the safety and the effectiveness of laparoscopy surgery conducted for advanced gastric cancers. Consequently, our case report will contribute to establish the ideal surgical method for the advanced gastric cancer patients.
Read the detailed description
In both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. As a general rule, Billroth II method will be used for gastric reconstruction for all cases.Billroth II gastrectomy is to link the gastric pouch to the jejunum 10~15 cm distal to the ligament of Treitz. An antecolic or retrocolic gastrojejunostomy connects the jejunum to the stomach in one continuous segment. For anastomosis, absorbable suture is used. Anastomotic diameter is 5~6 cm length. Drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.
- Conditions
- Stomach Neoplasm
- Being tested
- laparoscopy-assisted distal gastrectomy, open distal gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopy-assisted distal gastrectomyProcedure or surgery
Also called LADG
10 mm trocar under umbilicus, 12 mm and 5 mm trocar at the right flank area are inserted into abdominal wall. Another two 5 mm trocar are inserted into the both midline of subcostal line. The devices for operation are inserted through the trocars. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. As a general rule, Billroth II method was used for gastric reconstruction for all cases.Dissected stomach and lymph node are collected through additional 3~5 cm incision at the preexisting epigastric incision.Finally, Billroth II reconstruction is performed.
open distal gastrectomyProcedure or surgery
Also called ODG
Approximately 15~20 cm length incision is made from falciform process to periumbilical area. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. As a general rule, Billroth II method was used for gastric reconstruction for all cases.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Not described Receives: Procedure: open distal gastrectomy |
| 1 | Experimental | Not described Receives: Procedure: laparoscopy-assisted distal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 year survival
Measured: two year
Secondary outcomes (1)
efficacy and clinical out come
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Investigators
- Wook Kim, Professor, Study chair, Department of Surgery, Holy Family Hospital. The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741676
- Sponsor's protocol ID
- HFHGS01
- Status last verified
- Aug 2008
- First submitted
- 25 Aug 2008
- Last updated
- 31 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yano H, Monden T, Kinuta M, Nakano Y, Tono T, Matsui S, Iwazawa T, Kanoh T, Katsushima S. The usefulness of laparoscopy-assisted distal gastrectomy in comparison with that of open distal gastrectomy for early gastric cancer. Gastric Cancer. 2001;4(2):93-7. doi: 10.1007/pl00011730.
PubMed 11706767Mochiki E, Kamiyama Y, Aihara R, Nakabayashi T, Asao T, Kuwano H. Laparoscopic assisted distal gastrectomy for early gastric cancer: Five years' experience. Surgery. 2005 Mar;137(3):317-22. doi: 10.1016/j.surg.2004.10.012.
PubMed 15746786Morita M, Baba H, Fukuda T, Taketomi A, Kohnoe S, Seo Y, Saito T, Tomoda H, Sugimachi K. Submucosal gastric cancer with lymph node metastasis. J Surg Oncol. 1998 May;68(1):5-10. doi: 10.1002/(sici)1096-9098(199805)68:13.0.co;2-b.
PubMed 9610656Nakajima T. Gastric cancer treatment guidelines in Japan. Gastric Cancer. 2002;5(1):1-5. doi: 10.1007/s101200200000.
PubMed 12021853Noshiro H, Nagai E, Shimizu S, Uchiyama A, Tanaka M. Laparoscopically assisted distal gastrectomy with standard radical lymph node dissection for gastric cancer. Surg Endosc. 2005 Dec;19(12):1592-6. doi: 10.1007/s00464-005-0175-9. Epub 2005 Oct 24.
PubMed 16247578Lee JH, Kim YW, Ryu KW, Lee JR, Kim CG, Choi IJ, Kook MC, Nam BH, Bae JM. A phase-II clinical trial of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer patients. Ann Surg Oncol. 2007 Nov;14(11):3148-53. doi: 10.1245/s10434-007-9446-0. Epub 2007 Aug 20.
PubMed 17705092Ageno W, Squizzato A, Garcia D, Imberti D. Epidemiology and risk factors of venous thromboembolism. Semin Thromb Hemost. 2006 Oct;32(7):651-8. doi: 10.1055/s-2006-951293.
PubMed 17024592Huscher CG, Mingoli A, Sgarzini G, Brachini G, Binda B, Di Paola M, Ponzano C. Totally laparoscopic total and subtotal gastrectomy with extended lymph node dissection for early and advanced gastric cancer: early and long-term results of a 100-patient series. Am J Surg. 2007 Dec;194(6):839-44; discussion 844. doi: 10.1016/j.amjsurg.2007.08.037.
PubMed 18005781Sasako M, Saka M, Fukagawa T, Katai H, Sano T. Surgical treatment of advanced gastric cancer: Japanese perspective. Dig Surg. 2007;24(2):101-7. doi: 10.1159/000101896. Epub 2007 Apr 19.
PubMed 17446702Song KY, Kim SN, Park CH. Laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer: technical and oncologic aspects. Surg Endosc. 2008 Mar;22(3):655-9. doi: 10.1007/s00464-007-9431-5.
PubMed 17593447Kim MC, Kim KH, Kim HH, Jung GJ. Comparison of laparoscopy-assisted by conventional open distal gastrectomy and extraperigastric lymph node dissection in early gastric cancer. J Surg Oncol. 2005 Jul 1;91(1):90-4. doi: 10.1002/jso.20271.
PubMed 15999352Hur H, Jeon HM, Kim W. Laparoscopic pancreas- and spleen-preserving D2 lymph node dissection in advanced (cT2) upper-third gastric cancer. J Surg Oncol. 2008 Feb 1;97(2):169-72. doi: 10.1002/jso.20927.
PubMed 18095269Lee J, Kim W. Long-term outcomes after laparoscopy-assisted gastrectomy for advanced gastric cancer: analysis of consecutive 106 experiences. J Surg Oncol. 2009 Dec 15;100(8):693-8. doi: 10.1002/jso.21400.
PubMed 19731245
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy (ODG) for Advanced Gastric Cancer (Stage Ib and II).
- ClinicalTrials.gov ID
- NCT00741676
- Acronym / sponsor ID
- HFHGS01
- Conditions
- Stomach Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 26 Aug 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.
Among surgical methods for gastric cancer, incision about 15 ~20 cm length is prepared for open gastric cancer surgery while 0.5 ~ 1.2 cm is for laparoscopy gastric cancer surgery. Complications such as pain, abdominal adhesion, and problems associated with delayed recovery are common in open surgery because of large incision; however, those complications are less common in laparoscopy surgery because small sized incision is prepared. Range of surgery for curative dissection depends on the level of progress of a cancer, i.e., depends on whether gastric wall invasion, lymph node metastasis, or invasion to adjacent organs presented. Since recurrence in the lymph nodes after the operation is very common, the most important step in the gastric surgery is to dissect lymph node completely. According to the gastric cancer surgery manual published by Japan Gastric Cancer Association, more than D2 lymph node dissection is essential for improving survival rate in advanced gastric cancer. More than D2 lymph node dissection is relatively safely conducted by open surgery, whereas it is controversial in laparoscopy surgery because it is very hard to maintain surgical field under laparoscopic condition. Recently, widened rage of lymph node dissection by using laparoscopy is possible as laparoscopic surgical techniques are accumulated and new surgical devices are introduced. According to the case reports, D2 lymph node dissection by laparoscopy surgery shows similar results to the one by open surgery in aspects of recurrence rate and the number of dissected lymph node. Also, according to Hur and el., in case of upper gastric cancer, laparoscopy surgery is more useful to dissect #10 and #11 lymph node.In our prospective case study, the investigators would like to compare effectiveness, complications, patterns of recurrence, and survival rate between the two surgical approaches, laparoscopy distal gastrectomy and open distal gastrectomy. The investigators randomly operate the advanced gastric cancer patients, who need distal gastrectomy and D2 lymph node dissection. Surgical methods are selected randomly whether open surgery or laparoscopy surgery. Finally, the investigators wish our case report to contribute to the establishment of the safety and the effectiveness of laparoscopy surgery conducted for advanced gastric cancers. Consequently, our case report will contribute to establish the ideal surgical method for the advanced gastric cancer patients.
Detailed description
In both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. As a general rule, Billroth II method will be used for gastric reconstruction for all cases.Billroth II gastrectomy is to link the gastric pouch to the jejunum 10~15 cm distal to the ligament of Treitz. An antecolic or retrocolic gastrojejunostomy connects the jejunum to the stomach in one continuous segment. For anastomosis, absorbable suture is used. Anastomotic diameter is 5~6 cm length. Drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Procedure: open distal gastrectomy |
| 1 | Experimental | Procedure: laparoscopy-assisted distal gastrectomy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma
- Age: older than 20 year old, younger than 80 year old
- Cancer core: located at the middle or lower part of stomach
- Preoperative cancer stage (CT, GFS stage): cT2N0M0, cT2aN1M0, cT2bN1M0, cT3N0M0
- ASA score: ≤ 3
Key exclusion criteria (6 listed)
- Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
- Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
- Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
- Patient who was treated because of systemic inflammatory disease
- Pregnant patient
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 |
|---|---|---|
| laparoscopy-assisted distal gastrectomyAlso: LADG10 mm trocar under umbilicus, 12 mm and 5 mm trocar at the right flank area are inserted into abdominal wall. Another two 5 mm trocar are inserted into the both midline of subcostal line. The devices for operation are inserted through the trocars. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. As a general rule, Billroth II method was used for gastric reconstruction for all cases.Dissected stomach and lymph node are collected through additional 3~5 cm incision at the preexisting epigastric incision.Finally, Billroth II reconstruction is performed. | Procedure or surgery | 1 |
| open distal gastrectomyAlso: ODGApproximately 15~20 cm length incision is made from falciform process to periumbilical area. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. As a general rule, Billroth II method was used for gastric reconstruction for all cases. | Procedure or surgery | 2 |
Primary outcome
2 year survival
Time frame: two year
1 secondary outcome
efficacy and clinical out come
Time frame: two year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2008.
- Background: PubMed 11706767Yano H, Monden T, Kinuta M, Nakano Y, Tono T, Matsui S, Iwazawa T, Kanoh T, Katsushima S. The usefulness of laparoscopy-assisted distal gastrectomy in comparison with that of open distal gastrectomy for early gastric cancer. Gastric Cancer. 2001;4(2):93-7. doi: 10.1007/pl00011730.
- Background: PubMed 15746786Mochiki E, Kamiyama Y, Aihara R, Nakabayashi T, Asao T, Kuwano H. Laparoscopic assisted distal gastrectomy for early gastric cancer: Five years' experience. Surgery. 2005 Mar;137(3):317-22. doi: 10.1016/j.surg.2004.10.012.
- Background: PubMed 9610656Morita M, Baba H, Fukuda T, Taketomi A, Kohnoe S, Seo Y, Saito T, Tomoda H, Sugimachi K. Submucosal gastric cancer with lymph node metastasis. J Surg Oncol. 1998 May;68(1):5-10. doi: 10.1002/(sici)1096-9098(199805)68:13.0.co;2-b.
- Background: PubMed 12021853Nakajima T. Gastric cancer treatment guidelines in Japan. Gastric Cancer. 2002;5(1):1-5. doi: 10.1007/s101200200000.
- Background: PubMed 16247578Noshiro H, Nagai E, Shimizu S, Uchiyama A, Tanaka M. Laparoscopically assisted distal gastrectomy with standard radical lymph node dissection for gastric cancer. Surg Endosc. 2005 Dec;19(12):1592-6. doi: 10.1007/s00464-005-0175-9. Epub 2005 Oct 24.
- Background: PubMed 17705092Lee JH, Kim YW, Ryu KW, Lee JR, Kim CG, Choi IJ, Kook MC, Nam BH, Bae JM. A phase-II clinical trial of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer patients. Ann Surg Oncol. 2007 Nov;14(11):3148-53. doi: 10.1245/s10434-007-9446-0. Epub 2007 Aug 20.
- Background: PubMed 17024592Ageno W, Squizzato A, Garcia D, Imberti D. Epidemiology and risk factors of venous thromboembolism. Semin Thromb Hemost. 2006 Oct;32(7):651-8. doi: 10.1055/s-2006-951293.
- Background: PubMed 18005781Huscher CG, Mingoli A, Sgarzini G, Brachini G, Binda B, Di Paola M, Ponzano C. Totally laparoscopic total and subtotal gastrectomy with extended lymph node dissection for early and advanced gastric cancer: early and long-term results of a 100-patient series. Am J Surg. 2007 Dec;194(6):839-44; discussion 844. doi: 10.1016/j.amjsurg.2007.08.037.
- Background: PubMed 17446702Sasako M, Saka M, Fukagawa T, Katai H, Sano T. Surgical treatment of advanced gastric cancer: Japanese perspective. Dig Surg. 2007;24(2):101-7. doi: 10.1159/000101896. Epub 2007 Apr 19.
- Background: PubMed 17593447Song KY, Kim SN, Park CH. Laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer: technical and oncologic aspects. Surg Endosc. 2008 Mar;22(3):655-9. doi: 10.1007/s00464-007-9431-5.
- Background: PubMed 15999352Kim MC, Kim KH, Kim HH, Jung GJ. Comparison of laparoscopy-assisted by conventional open distal gastrectomy and extraperigastric lymph node dissection in early gastric cancer. J Surg Oncol. 2005 Jul 1;91(1):90-4. doi: 10.1002/jso.20271.
- Background: PubMed 18095269Hur H, Jeon HM, Kim W. Laparoscopic pancreas- and spleen-preserving D2 lymph node dissection in advanced (cT2) upper-third gastric cancer. J Surg Oncol. 2008 Feb 1;97(2):169-72. doi: 10.1002/jso.20927.
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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, Professor study chair
Department of Surgery, Holy Family Hospital. The Catholic University of Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing laparoscopy-assisted distal gastrectomy and open distal gastrectomy in people with Stomach Neoplasm, run by The Catholic University of Korea at 2 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 6 inclusion and 6 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 31 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Wook Kim, professor (82-32-340-7022, kimwook@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 year survival (time frame: two year). 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 NCT00741676, which also lists 13 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 31 Dec 2008.