Gastric CancerPhase 2KLASS-03NCT01584336
Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)
A Phase 2 study testing LATG in people with Gastric Cancer, run by Soonchunhyang University Hospital at 10 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and feasibility of laparoscopy-assisted total gastrectomy for early upper gastric cancer compared with open total gastrectomy. This study will performed via prospective, multicenter design. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- LATG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Oct 2012to Mar 2014
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy
- range of age ; over 20 years to under 80 years
- preoperative stage : cT1N0M0, cT1N1M0, cT2N0M0 (7th UICC)
- The patient who is needed the total gastrectomy because the upper margin of cancer is located between upper 1cm and lower 5cm to esophagogastric junction
- the gastric cancer which is not included the indication of the endoscopic mucosal dissection
- ECOG (Eastern Cooperative Oncology Group) performance status; 0 and 1
- ASA (American Society of Anesthesiology) score ; 1, 2, 3
- Written informed consent
Who cannot join
- The patient who shows distant metastasis under preoperative examination
- The patient with medical history for upper abdominal surgery with open method in the past
- The patient with medical history for distal gastrectomy due to benign or malignant gastric disease in the past(remnant stomach cancer)
- The patient with double cancer synchronous or metachronous within 5 years
- Enlarged lymph nodes of the splenic hilum in the preoperative evaluation
- The patient who has been enrolled other clinical study within 6 months
- Vulnerable patients who lacks mental capacity and are pregnant or planning a pregnancy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Recruiting
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 420-767
Gyu Seok Cho, M.D., Ph.D., +82-32-621-5814, gschogs@schmc.ac.kr
Gui Ae Jeong, M.D., Ph.D., +82-32-621-5834, gwsdlove@schmc.ac.kr
- Recruiting
Keimyung University Dongsan Medical Center
Daegu, 700-712
Seung Wan Ryu, M.D., Ph.D., +82-53-250-8322, gsman@dsmc.or.kr
Seung Wan Ryu, M.D., Ph.D
- Recruiting
Kyungpook National University medical Center
Daegu, 702-210
Oh Kyoung Kwon, M.D., Ph.D., +82-53-200-3062, kok007@hanmail.net
Oh Kyoung Kwon, M.D., Ph.D.
- Recruiting
Incheon St, Mary's Hostpial, The Catholic University of Korea
Incheon, 403-720
Jin Jo Kim, M.D., +82-1544-9004, kjj@catholic.ac.kr
Jin Jo Kim, M.D.
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Seong Ho Kong, M.D., Ph.D., +82-2-2072-2114, wisehearted@gmail.com
Seong Ho Kong, M.D., Ph.D.
- Recruiting
Seoul National University Hospital
Seoul, 110-799
Han Kwang Yang, M.D., Ph.D., +82-2-2072-3797, hkyang@snu.ac.kr
Han Kwang Yang, M.D., Ph.D.
- Recruiting
Seoul National University Hospital
Seoul, 110-799
Hyuk Joon Lee, M.D., Ph.D., +82-2-2072-1957, appe98@snu.ac.kr
Hyuk Joon Lee, M.D., Ph.D.
- Recruiting
Yonsei University Severance Hospital
Seoul, 120-752
Woo Jin Hyung, M.D., Ph.D., +82-2-2227-0114, wjhyung@yumc.yonsei.ac.kr
Woo Jin Hyung, M.D., Ph.D.
- Recruiting
Yonsei University Severance Hospital
Seoul, 120-752
Hyoung Il Kim, M.D., +82-2-2227-0114, cairus@naver.com
Hyoung Il Kim, M.D., Ph.D.
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 443-749
Sang Uk Han, M.D., Ph.D., +82-31-219-5200, hansu@ajou.ac.kr
Sang Uk Han, M.D., Ph.D.
About this study
Official title: Prospective Multi-center Study of Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)
The purpose of this study is to evaluate the safety and feasibility of laparoscopy-assisted total gastrectomy for early upper gastric cancer compared with open total gastrectomy. This study will performed via prospective, multicenter design.
Read the detailed description
Gastric cancer remains one of the most common neoplasms in Asia and some western countries, although the incidence is decreasing worldwide. Recently,as the rate of detection of early gastric cancer has increased and surgical techniques have been developed, laparoscopic procedures have been introduced and tried for the treatment of early-stage gastric cancer.
Already the prospective, randomized trials for safety and oncologic outcomes of laparoscopy-assisted distal gastrectomy for gastric cancer had been tried, but the large-scaled, prospective study for laparoscopy-assisted total gastrectomy (LATG) is seldom.
One reason for the low popularity is that LATG requires the dissection of lymph nodes at the splenic hilum or along the short gastric arteries and the other reason is that the reconstruction after total gastrectomy is also more complicated. The third reason is that the chance for total gastrectomy is less frequent than distal gastrectomy because of the low incidence of upper gastric cancer.
This KLASS-03 trial is a prospective, multicenter trial for LATG for early upper gastric cancer. The primary purpose of this study is to evaluate the incidence of postoperative morbidity and mortality and the second purpose is to evaluate the surgical outcomes after several methods of reconstruction in laparoscopic total gastrectomy and the postoperative course of LATG patients.
- Conditions
- Gastric Cancer
- Being tested
- LATG
- Keywords
- Gastric cancer, laparoscopy-assisted total 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.
LATGProcedure or surgery
Also called Laparoscopy-assisted total gastrectomy (LATG)
- After laparoscopic observation, the surgeon must check the possibility of laparoscopic surgery (without the serosal invasion of cancer or peritoneal metastasis or lymph node metastasis to splenic hilum). If the gastric cancer with serosal invasion or grossly lymph node metastasis to splenic hilum, operator must convert the operation method to open gastrectomy
- The operator undergoes the laparoscopic total gastrectomy with lymph node dissection(including the status of lymph nodes - No #1,2,3,4sa,4sb,4d,5,6,7,8a,9,11p and 11d, and/or 12a).
- The operator can choose any reconstruction method of esophagojejunostomy according to surgeon's preference.
- After then, the operator performs the jejunojejunostomy.
| Study group | Role | What they receive |
|---|---|---|
| LATG group | Experimental | It means the patients who will be enrolled in our study. Receives: Procedure: LATG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative morbidity and mortality
The primary purpose of this study is that the incidence of morbidity and mortality after LATG. We will access the postoperative morbidity including as follows: wound complication, intra-abdominal fluid collection or abscess, intra-abdominal bleeding, intraluminal bleeding, intestinal obstruction, ileus, anastomotic stenosis, anastomotic leakage, fistula, pancreatitis, pulmonary complication, urinary complication, renal complication, hepatic complication, cardiac complication, endocrine complication, and stasis.
Also we will evaluate the incidence of postoperative mortality after LATG.
Measured: 1 month
Secondary outcomes (1)
the surgical outcomes according to the method of reconstruction
We will evaluate the difference of surgical outcomes (duration of anastomosis, failure rate of anastomosis, etc) and postoperative morbidity (anastomotic leakage, stenosis, bleeding, etc) according to the methods of reconstruction after gastrectomy. The methods of reconstruction after gastrectomy will be depend to the each operator's decision.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2014
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gyu-Seok Cho, Soonchunhyang University Hospital
- Investigators
- Gyu-Seok Cho, M.D., Ph.D., Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584336
- Sponsor's protocol ID
- KLASS-03
- Acronym
- KLASS-03
- Status last verified
- Feb 2014
- First submitted
- 22 Apr 2012
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim SG, Lee YJ, Ha WS, Jung EJ, Ju YT, Jeong CY, Hong SC, Choi SK, Park ST, Bae K. LATG with extracorporeal esophagojejunostomy: is this minimal invasive surgery for gastric cancer? J Laparoendosc Adv Surg Tech A. 2008 Aug;18(4):572-8. doi: 10.1089/lap.2007.0106.
PubMed 18721007Kunisaki C, Makino H, Oshima T, Fujii S, Kimura J, Takagawa R, Kosaka T, Akiyama H, Morita S, Endo I. Application of the transorally inserted anvil (OrVil) after laparoscopy-assisted total gastrectomy. Surg Endosc. 2011 Apr;25(4):1300-5. doi: 10.1007/s00464-010-1367-5. Epub 2010 Oct 17.
PubMed 20953884Nunobe S, Hiki N, Tanimura S, Kubota T, Kumagai K, Sano T, Yamaguchi T. Three-step esophagojejunal anastomosis with atraumatic anvil insertion technique after laparoscopic total gastrectomy. J Gastrointest Surg. 2011 Sep;15(9):1520-5. doi: 10.1007/s11605-011-1489-7. Epub 2011 May 10.
PubMed 21557017Okabe H, Obama K, Tanaka E, Nomura A, Kawamura J, Nagayama S, Itami A, Watanabe G, Kanaya S, Sakai Y. Intracorporeal esophagojejunal anastomosis after laparoscopic total gastrectomy for patients with gastric cancer. Surg Endosc. 2009 Sep;23(9):2167-71. doi: 10.1007/s00464-008-9987-8. Epub 2008 Jun 14.
PubMed 18553203Kim MG, Kim BS, Kim TH, Kim KC, Yook JH, Kim BS. The effects of laparoscopic assisted total gastrectomy on surgical outcomes in the treatment of gastric cancer. J Korean Surg Soc. 2011 Apr;80(4):245-50. doi: 10.4174/jkss.2011.80.4.245. Epub 2011 Apr 12.
PubMed 22066043Kanagale P, Lohray BB, Misra A, Davadra P, Kini R. Formulation and optimization of porous osmotic pump-based controlled release system of oxybutynin. AAPS PharmSciTech. 2007 Jul 13;8(3):E53. doi: 10.1208/pt0803053.
PubMed 17915803Mochiki E, Toyomasu Y, Ogata K, Andoh H, Ohno T, Aihara R, Asao T, Kuwano H. Laparoscopically assisted total gastrectomy with lymph node dissection for upper and middle gastric cancer. Surg Endosc. 2008 Sep;22(9):1997-2002. doi: 10.1007/s00464-008-0015-9. Epub 2008 Jul 2.
PubMed 18594925Kawamura H, Yokota R, Homma S, Kondo Y. Comparison of invasiveness between laparoscopy-assisted total gastrectomy and open total gastrectomy. World J Surg. 2009 Nov;33(11):2389-95. doi: 10.1007/s00268-009-0208-y.
PubMed 19760315Tanimura S, Higashino M, Fukunaga Y, Takemura M, Tanaka Y, Fujiwara Y, Osugi H. Laparoscopic gastrectomy for gastric cancer: experience with more than 600 cases. Surg Endosc. 2008 May;22(5):1161-4. doi: 10.1007/s00464-008-9786-2. Epub 2008 Mar 6.
PubMed 18322744Lee SE, Ryu KW, Nam BH, Lee JH, Kim YW, Yu JS, Cho SJ, Lee JY, Kim CG, Choi IJ, Kook MC, Park SR, Kim MJ, Lee JS. Technical feasibility and safety of laparoscopy-assisted total gastrectomy in gastric cancer: a comparative study with laparoscopy-assisted distal gastrectomy. J Surg Oncol. 2009 Oct 1;100(5):392-5. doi: 10.1002/jso.21345.
PubMed 19598150
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-center Study of Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)
- ClinicalTrials.gov ID
- NCT01584336
- Acronym / sponsor ID
- KLASS-03 / KLASS-03
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, laparoscopy-assisted total gastrectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (estimated)
- First posted
- 24 Apr 2012 (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 safety and feasibility of laparoscopy-assisted total gastrectomy for early upper gastric cancer compared with open total gastrectomy. This study will performed via prospective, multicenter design.
Detailed description
Gastric cancer remains one of the most common neoplasms in Asia and some western countries, although the incidence is decreasing worldwide. Recently,as the rate of detection of early gastric cancer has increased and surgical techniques have been developed, laparoscopic procedures have been introduced and tried for the treatment of early-stage gastric cancer.
Already the prospective, randomized trials for safety and oncologic outcomes of laparoscopy-assisted distal gastrectomy for gastric cancer had been tried, but the large-scaled, prospective study for laparoscopy-assisted total gastrectomy (LATG) is seldom.
One reason for the low popularity is that LATG requires the dissection of lymph nodes at the splenic hilum or along the short gastric arteries and the other reason is that the reconstruction after total gastrectomy is also more complicated. The third reason is that the chance for total gastrectomy is less frequent than distal gastrectomy because of the low incidence of upper gastric cancer.
This KLASS-03 trial is a prospective, multicenter trial for LATG for early upper gastric cancer. The primary purpose of this study is to evaluate the incidence of postoperative morbidity and mortality and the second purpose is to evaluate the surgical outcomes after several methods of reconstruction in laparoscopic total gastrectomy and the postoperative course of LATG patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LATG group | Experimental | Procedure: LATGIt means the patients who will be enrolled in our study. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy
- range of age ; over 20 years to under 80 years
- preoperative stage : cT1N0M0, cT1N1M0, cT2N0M0 (7th UICC)
- The patient who is needed the total gastrectomy because the upper margin of cancer is located between upper 1cm and lower 5cm to esophagogastric junction
- the gastric cancer which is not included the indication of the endoscopic mucosal dissection
Key exclusion criteria (7 listed)
- The patient who shows distant metastasis under preoperative examination
- The patient with medical history for upper abdominal surgery with open method in the past
- The patient with medical history for distal gastrectomy due to benign or malignant gastric disease in the past(remnant stomach cancer)
- The patient with double cancer synchronous or metachronous within 5 years
- Enlarged lymph nodes of the splenic hilum in the preoperative evaluation
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 |
|---|---|---|
| LATGAlso: Laparoscopy-assisted total gastrectomy (LATG)1. After laparoscopic observation, the surgeon must check the possibility of laparoscopic surgery (without the serosal invasion of cancer or peritoneal metastasis or lymph node metastasis to splenic hilum). If the gastric cancer with serosal invasion or grossly lymph node metastasis to splenic hilum, operator must convert the operation method to open gastrectomy 2. The operator undergoes the laparoscopic total gastrectomy with lymph node dissection(including the status of lymph nodes - No #1,2,3,4sa,4sb,4d,5,6,7,8a,9,11p and 11d, and/or 12a). 3. The operator can choose any reconstruction method of esophagojejunostomy according to surgeon's preference. 4. After then, the operator performs the jejunojejunostomy. | Procedure or surgery | LATG group |
Primary outcome
The incidence of postoperative morbidity and mortality
Time frame: 1 month
The primary purpose of this study is that the incidence of morbidity and mortality after LATG. We will access the postoperative morbidity including as follows: wound complication, intra-abdominal fluid collection or abscess, intra-abdominal bleeding, intraluminal bleeding, intestinal obstruction, ileus, anastomotic stenosis, anastomotic leakage, fistula, pancreatitis, pulmonary complication, urinary complication, renal complication, hepatic complication, cardiac complication, endocrine complication, and stasis. Also we will evaluate the incidence of postoperative mortality after LATG.
1 secondary outcome
the surgical outcomes according to the method of reconstruction
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
- Background: PubMed 18721007Kim SG, Lee YJ, Ha WS, Jung EJ, Ju YT, Jeong CY, Hong SC, Choi SK, Park ST, Bae K. LATG with extracorporeal esophagojejunostomy: is this minimal invasive surgery for gastric cancer? J Laparoendosc Adv Surg Tech A. 2008 Aug;18(4):572-8. doi: 10.1089/lap.2007.0106.
- Background: PubMed 20953884Kunisaki C, Makino H, Oshima T, Fujii S, Kimura J, Takagawa R, Kosaka T, Akiyama H, Morita S, Endo I. Application of the transorally inserted anvil (OrVil) after laparoscopy-assisted total gastrectomy. Surg Endosc. 2011 Apr;25(4):1300-5. doi: 10.1007/s00464-010-1367-5. Epub 2010 Oct 17.
- Background: PubMed 21557017Nunobe S, Hiki N, Tanimura S, Kubota T, Kumagai K, Sano T, Yamaguchi T. Three-step esophagojejunal anastomosis with atraumatic anvil insertion technique after laparoscopic total gastrectomy. J Gastrointest Surg. 2011 Sep;15(9):1520-5. doi: 10.1007/s11605-011-1489-7. Epub 2011 May 10.
- Background: PubMed 18553203Okabe H, Obama K, Tanaka E, Nomura A, Kawamura J, Nagayama S, Itami A, Watanabe G, Kanaya S, Sakai Y. Intracorporeal esophagojejunal anastomosis after laparoscopic total gastrectomy for patients with gastric cancer. Surg Endosc. 2009 Sep;23(9):2167-71. doi: 10.1007/s00464-008-9987-8. Epub 2008 Jun 14.
- Results publication: PubMed 22066043Kim MG, Kim BS, Kim TH, Kim KC, Yook JH, Kim BS. The effects of laparoscopic assisted total gastrectomy on surgical outcomes in the treatment of gastric cancer. J Korean Surg Soc. 2011 Apr;80(4):245-50. doi: 10.4174/jkss.2011.80.4.245. Epub 2011 Apr 12.
- Results publication: PubMed 17915803Kanagale P, Lohray BB, Misra A, Davadra P, Kini R. Formulation and optimization of porous osmotic pump-based controlled release system of oxybutynin. AAPS PharmSciTech. 2007 Jul 13;8(3):E53. doi: 10.1208/pt0803053.
- Results publication: PubMed 18594925Mochiki E, Toyomasu Y, Ogata K, Andoh H, Ohno T, Aihara R, Asao T, Kuwano H. Laparoscopically assisted total gastrectomy with lymph node dissection for upper and middle gastric cancer. Surg Endosc. 2008 Sep;22(9):1997-2002. doi: 10.1007/s00464-008-0015-9. Epub 2008 Jul 2.
- Results publication: PubMed 19760315Kawamura H, Yokota R, Homma S, Kondo Y. Comparison of invasiveness between laparoscopy-assisted total gastrectomy and open total gastrectomy. World J Surg. 2009 Nov;33(11):2389-95. doi: 10.1007/s00268-009-0208-y.
- Results publication: PubMed 18322744Tanimura S, Higashino M, Fukunaga Y, Takemura M, Tanaka Y, Fujiwara Y, Osugi H. Laparoscopic gastrectomy for gastric cancer: experience with more than 600 cases. Surg Endosc. 2008 May;22(5):1161-4. doi: 10.1007/s00464-008-9786-2. Epub 2008 Mar 6.
- Results publication: PubMed 19598150Lee SE, Ryu KW, Nam BH, Lee JH, Kim YW, Yu JS, Cho SJ, Lee JY, Kim CG, Choi IJ, Kook MC, Park SR, Kim MJ, Lee JS. Technical feasibility and safety of laparoscopy-assisted total gastrectomy in gastric cancer: a comparative study with laparoscopy-assisted distal gastrectomy. J Surg Oncol. 2009 Oct 1;100(5):392-5. doi: 10.1002/jso.21345.
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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.
Gyu-Seok Cho, M.D., Ph.D. principal investigator
Soonchunhyang University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LATG in people with Gastric Cancer, run by Soonchunhyang University Hospital at 10 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 8 inclusion and 7 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 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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 Gyu-Seok Cho, M.D., Ph.D. (+82-32-621-5248, gschogs@schmc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative morbidity and mortality (time frame: 1 month). 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 NCT01584336, which also lists 10 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 6 Feb 2014.