Gastric CancerNCT03500471
Robotic and Laparoscopic Total Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer
An observational study of Gastric Cancer, run by Southwest Hospital, China at 1 site in China.
Trial summary
This study is a prospective, single-center, non-randomized, controlled, non-blind, and non-inferiority observation trial comparing robotic-assisted total gastrectomy with D2 lymph nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Robotic-assisted Total Gastrectomy and Laparoscopic-assisted Total Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2018to 30 Aug 2021
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with gastric cancer who need to received total gastrectomy with D2 lymphadenectomy.
Who may be able to join
- Pathologically proven gastric adenocarcinoma;
- Age: older than 18 years old, younger than 80 years old;
- Tumor located in the upper third of the stomach or esophagogastric junction or other location, and is possible to be curatively resected by total gastrectomy;
- Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition;
- American Society of Anesthesiology (ASA) score of class I to III;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Patients who freely give informed consent to participate in the clinical study;
Who cannot join
- Early gastric cancer;
- Age: younger than 18 years old, older than 80 years old;
- Total gastrectomy with D2 lymphadenectomy was not required;
- Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
- Emergency surgery for gastric cancer-related complications (bleeding or complete obstruction or perforation);
- Previous upper abdominal surgery (except laparoscopic cholecystectomy);
Show all 13Show fewer
- Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer;
- Unstable angina or myocardial infarction within the past 6 months;
- Cerebrovascular accident within the past 6 months;
- American Society of Anesthesiology (ASA) score of class more than III;
- Severe respiratory disease (FEV1< 50%);
- Continuous systemic steroid therapy within 1 month before the study;
- Pregnant or breast-feeding women;
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery,Southwest Hospital
Chongqing, Chongqing Municipality, 400038
About this study
Official title: Safety and Feasibility Between Robotic and Laparoscopic Total Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer：A Prospective Cohort Study
This study is a prospective, single-center, non-randomized, controlled, non-blind, and non-inferiority observation trial comparing robotic-assisted total gastrectomy with D2 lymph nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure.
Read the detailed description
Since Kitano firstly reported laparoscopy-assisted distal gastrectomy in 1994, the number of patients undergoing the laparoscopic procedure has gradually increased. The latest Japanese gastric cancer treatment guideline recommends laparoscopic gastrectomy (LG) as an optional treatment for cStage Ⅰ gastric cancer (GC).
Based on the experience of early GC, most experienced surgeons have applied the laparoscopic procedure in patients with locally advanced gastric cancer (AGC) especially in east world like China, Japan and Korea. Though applying laparoscopic-assisted total gastrectomy (LATG) is much more difficulty than that of distal gastrectomy (DG), there are a mount of centers reported their experiences of this procedure. A meta-analysis including seventeen studies of 2313 patients (955 in LATG and 1358 in open total gastrectomy) demonstrated that LATG can have less blood loss, fewer analgesic uses, earlier passage of flatus, quicker resumption of oral intake, earlier hospital discharge, and reduced postoperative morbidity. However, the number of harvested lymph nodes, proximal resection margin, hospital mortality, 5-year OS and DFS were similar in both groups. According to the existing reports, LATG is technically safety and feasibility.
To overcome the limitations of laparoscopic surgery, robot systems have been introduced to treat GC providing technical advantages since Hashizume firstly reported. Yoon and Son respectively compared robot-assisted total gastrectomy (RATG) with LATG, they drew a common conclusion that the number of dissected lymph nodes and postoperative complications were similar in both groups. But Son found that the mean numbers of retrieved LNs along the splenic artery from RATG was higher than LATG (2.3 vs. 1.0, p = 0.013), as was also the case at the splenic hilum and artery (3.6 vs.1.9, p = 0.014). Regretfully, most of their reported cases were early gastric cancer (EGC). Other literatures reported AGC patients under RATG or LATG together with distal gastrectomy (DG), we haven't found any literature compare RATG with LATG alone for AGC retrospectively.
Since most literatures are EGC patients and retrospectively researches, we can't insist that patients with AGC may benefit under RATG. Therefore, we launch this prospective, single-center, non-randomized, controlled, non-blind, and non-inferiority observation trial comparing RATG for locally advanced gastric cancer patients with LATG.In the process of research,it will be divided into two groups according to the willing of patients or their legal representatives who choose one of the two procedures(RATG or LATG) to cure GC.The primary objective of this study is to assess whether RATG is comparable to laparoscopic approach in terms of overall postoperative morbidity rates. The secondary research objectives are to compare robotic with laparoscopic approach in terms of surgical outcomes, postoperative recovery courses.
- Conditions
- Gastric Cancer
- Being tested
- Robotic-assisted Total Gastrectomy, Laparoscopic-assisted Total Gastrectomy
- Keywords
- Laparoscopic, Robotic, Total Gastrectomy, AGC
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted Total GastrectomyProcedure or surgery
Robotic-assisted total gastrectomy with D2 lymph node dissection will be performed with curative treated intent according to the patients' or their legal representatives'willing to choose robotic-assisted total gastrectomy and exclusing T4b、bulky lymph nodes or distant metastasis case by diagnostic laparoscopy. The alimentary canal reconstruction method is selected as esophageal jejunal R-Y anastomosis. Whether to reinforce the anastomotic manually is decided by the surgeon's experience. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
Laparoscopic-assisted Total GastrectomyProcedure or surgery
Laparoscopic-assisted total gastrectomy with D2 lymph node dissection will be performed with curative treated intent according to the patients' or their legal representatives'willing to choose laparoscopic-assisted total gastrectomy and exclusing T4b、bulky lymph nodes or distant metastasis case by diagnostic laparoscopy. The alimentary canal reconstruction method is selected as esophageal jejunal R-Y anastomosis. Whether to reinforce the anastomotic manually is decided by the surgeon's experience. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Robotic surgery | Robotic-assisted Total Gastrectomy with D2 Lymphadenectomy Receives: Procedure: Robotic-assisted Total Gastrectomy | |
| Compared: Laparoscopic surgery | Laparoscopic-assisted Total Gastrectomy with D2 Lymphadenectomy Receives: Procedure: Laparoscopic-assisted Total Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall postoperative morbidity and mortality
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
Measured: 30 days
Secondary outcomes (11)
Time of operation
The total time of operation
Measured: 1 day
Estimated blood loss
Blood loss during intraoperative including the volume of negative pressure drainage bottle and the increasing weight of gauzes （ml）
Measured: 1 day
Blood transfusion
Blood transfusion during operation
Measured: 1 day
Length of proximal and distal cutting margin
Length of proximal and distal cutting margin of the specimen
Measured: 1 day
Number of retrieved lymph nodes
Total number of harvested perigastric lymph node
Measured: 7 days
Time to flatus
Time of anus exsufflation
Measured: 30 days
Time to first ambulation
Time to walking about
Measured: 30 days
Time to liquid diet
Time to liquid diet
Measured: 30 days
Time to soft diet
Time to soft diet
Measured: 30 days
Duration of postoperative hospital stay
Time from operation to hospital discharge
Measured: 30 days
cost
All costs of hospitalization
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start16 Apr 2018
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Shi, Southwest Hospital, China
- Investigators
- Peiwu Yu, M.D., Study chair, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500471
- Sponsor's protocol ID
- 20180108
- Status last verified
- Sep 2021
- First submitted
- 28 Mar 2018
- Last updated
- 21 Oct 2021
- Results posted
- No
- Individual data sharing
- No
Publications
Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available.
PubMed 27342689Haverkamp L, Weijs TJ, van der Sluis PC, van der Tweel I, Ruurda JP, van Hillegersberg R. Laparoscopic total gastrectomy versus open total gastrectomy for cancer: a systematic review and meta-analysis. Surg Endosc. 2013 May;27(5):1509-20. doi: 10.1007/s00464-012-2661-1. Epub 2012 Dec 14.
PubMed 23263644Etoh T, Honda M, Kumamaru H, Miyata H, Yoshida K, Kodera Y, Kakeji Y, Inomata M, Konno H, Seto Y, Kitano S, Hiki N. Morbidity and mortality from a propensity score-matched, prospective cohort study of laparoscopic versus open total gastrectomy for gastric cancer: data from a nationwide web-based database. Surg Endosc. 2018 Jun;32(6):2766-2773. doi: 10.1007/s00464-017-5976-0. Epub 2017 Dec 7.
PubMed 29218676Yoon HM, Kim YW, Lee JH, Ryu KW, Eom BW, Park JY, Choi IJ, Kim CG, Lee JY, Cho SJ, Rho JY. Robot-assisted total gastrectomy is comparable with laparoscopically assisted total gastrectomy for early gastric cancer. Surg Endosc. 2012 May;26(5):1377-81. doi: 10.1007/s00464-011-2043-0. Epub 2011 Nov 16.
PubMed 22083338Son T, Lee JH, Kim YM, Kim HI, Noh SH, Hyung WJ. Robotic spleen-preserving total gastrectomy for gastric cancer: comparison with conventional laparoscopic procedure. Surg Endosc. 2014 Sep;28(9):2606-15. doi: 10.1007/s00464-014-3511-0. Epub 2014 Apr 3.
PubMed 24695982Shen W, Xi H, Wei B, Cui J, Bian S, Zhang K, Wang N, Huang X, Chen L. Robotic versus laparoscopic gastrectomy for gastric cancer: comparison of short-term surgical outcomes. Surg Endosc. 2016 Feb;30(2):574-580. doi: 10.1007/s00464-015-4241-7. Epub 2015 Jul 25.
PubMed 26208497Pan HF, Wang G, Liu J, Liu XX, Zhao K, Tang XF, Jiang ZW. Robotic Versus Laparoscopic Gastrectomy for Locally Advanced Gastric Cancer. Surg Laparosc Endosc Percutan Tech. 2017 Dec;27(6):428-433. doi: 10.1097/SLE.0000000000000469.
PubMed 29211699Junfeng Z, Yan S, Bo T, Yingxue H, Dongzhu Z, Yongliang Z, Feng Q, Peiwu Y. Robotic gastrectomy versus laparoscopic gastrectomy for gastric cancer: comparison of surgical performance and short-term outcomes. Surg Endosc. 2014 Jun;28(6):1779-87. doi: 10.1007/s00464-013-3385-6. Epub 2014 Jan 3.
PubMed 24385251Wang W, Zhang X, Shen C, Zhi X, Wang B, Xu Z. Laparoscopic versus open total gastrectomy for gastric cancer: an updated meta-analysis. PLoS One. 2014 Feb 18;9(2):e88753. doi: 10.1371/journal.pone.0088753. eCollection 2014.
PubMed 24558421
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Between Robotic and Laparoscopic Total Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer：A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03500471
- Acronym / sponsor ID
- 20180108
- Conditions
- Gastric Cancer
- Keywords
- Laparoscopic, Robotic, Total Gastrectomy, AGC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 18 Apr 2018 (actual)
- 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.
This study is a prospective, single-center, non-randomized, controlled, non-blind, and non-inferiority observation trial comparing robotic-assisted total gastrectomy with D2 lymph nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure.
Detailed description
Since Kitano firstly reported laparoscopy-assisted distal gastrectomy in 1994, the number of patients undergoing the laparoscopic procedure has gradually increased. The latest Japanese gastric cancer treatment guideline recommends laparoscopic gastrectomy (LG) as an optional treatment for cStage Ⅰ gastric cancer (GC).
Based on the experience of early GC, most experienced surgeons have applied the laparoscopic procedure in patients with locally advanced gastric cancer (AGC) especially in east world like China, Japan and Korea. Though applying laparoscopic-assisted total gastrectomy (LATG) is much more difficulty than that of distal gastrectomy (DG), there are a mount of centers reported their experiences of this procedure. A meta-analysis including seventeen studies of 2313 patients (955 in LATG and 1358 in open total gastrectomy) demonstrated that LATG can have less blood loss, fewer analgesic uses, earlier passage of flatus, quicker resumption of oral intake, earlier hospital discharge, and reduced postoperative morbidity. However, the number of harvested lymph nodes, proximal resection margin, hospital mortality, 5-year OS and DFS were similar in both groups. According to the existing reports, LATG is technically safety and feasibility.
To overcome the limitations of laparoscopic surgery, robot systems have been introduced to treat GC providing technical advantages since Hashizume firstly reported. Yoon and Son respectively compared robot-assisted total gastrectomy (RATG) with LATG, they drew a common conclusion that the number of dissected lymph nodes and postoperative complications were similar in both groups. But Son found that the mean numbers of retrieved LNs along the splenic artery from RATG was higher than LATG (2.3 vs. 1.0, p = 0.013), as was also the case at the splenic hilum and artery (3.6 vs.1.9, p = 0.014). Regretfully, most of their reported cases were early gastric cancer (EGC). Other literatures reported AGC patients under RATG or LATG together with distal gastrectomy (DG), we haven't found any literature compare RATG with LATG alone for AGC retrospectively.
Since most literatures are EGC patients and retrospectively researches, we can't insist that patients with AGC may benefit under RATG. Therefore, we launch this prospective, single-center, non-randomized, controlled, non-blind, and non-inferiority observation trial comparing RATG for locally advanced gastric cancer patients with LATG.In the process of research,it will be divided into two groups according to the willing of patients or their legal representatives who choose one of the two procedures(RATG or LATG) to cure GC.The primary objective of this study is to assess whether RATG is comparable to laparoscopic approach in terms of overall postoperative morbidity rates. The secondary research objectives are to compare robotic with laparoscopic approach in terms of surgical outcomes, postoperative recovery courses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Robotic surgery | – | Procedure: Robotic-assisted Total GastrectomyRobotic-assisted Total Gastrectomy with D2 Lymphadenectomy |
| Compared: Laparoscopic surgery | – | Procedure: Laparoscopic-assisted Total GastrectomyLaparoscopic-assisted Total Gastrectomy with D2 Lymphadenectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with gastric cancer who need to received total gastrectomy with D2 lymphadenectomy.
Key inclusion criteria (7 listed)
- Pathologically proven gastric adenocarcinoma;
- Age: older than 18 years old, younger than 80 years old;
- Tumor located in the upper third of the stomach or esophagogastric junction or other location, and is possible to be curatively resected by total gastrectomy;
- Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition;
- American Society of Anesthesiology (ASA) score of class I to III;
Key exclusion criteria (13 listed)
- Early gastric cancer;
- Age: younger than 18 years old, older than 80 years old;
- Total gastrectomy with D2 lymphadenectomy was not required;
- Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
- Emergency surgery for gastric cancer-related complications (bleeding or complete obstruction or perforation);
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 |
|---|---|---|
| Robotic-assisted Total GastrectomyRobotic-assisted total gastrectomy with D2 lymph node dissection will be performed with curative treated intent according to the patients' or their legal representatives'willing to choose robotic-assisted total gastrectomy and exclusing T4b、bulky lymph nodes or distant metastasis case by diagnostic laparoscopy. The alimentary canal reconstruction method is selected as esophageal jejunal R-Y anastomosis. Whether to reinforce the anastomotic manually is decided by the surgeon's experience. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis. | Procedure or surgery | Experimental: Robotic surgery |
| Laparoscopic-assisted Total GastrectomyLaparoscopic-assisted total gastrectomy with D2 lymph node dissection will be performed with curative treated intent according to the patients' or their legal representatives'willing to choose laparoscopic-assisted total gastrectomy and exclusing T4b、bulky lymph nodes or distant metastasis case by diagnostic laparoscopy. The alimentary canal reconstruction method is selected as esophageal jejunal R-Y anastomosis. Whether to reinforce the anastomotic manually is decided by the surgeon's experience. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis. | Procedure or surgery | Compared: Laparoscopic surgery |
Primary outcome
Overall postoperative morbidity and mortality
Time frame: 30 days
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
11 secondary outcomes
Time of operation
Time frame: 1 day
Estimated blood loss
Time frame: 1 day
Blood transfusion
Time frame: 1 day
Length of proximal and distal cutting margin
Time frame: 1 day
Number of retrieved lymph nodes
Time frame: 7 days
Time to flatus
Time frame: 30 days
Time to first ambulation
Time frame: 30 days
Time to liquid diet
Time frame: 30 days
Time to soft diet
Time frame: 30 days
Duration of postoperative hospital stay
Time frame: 30 days
cost
Time frame: 30days
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 21 Oct 2021.
- Background: PubMed 27342689Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available.
- Background: PubMed 23263644Haverkamp L, Weijs TJ, van der Sluis PC, van der Tweel I, Ruurda JP, van Hillegersberg R. Laparoscopic total gastrectomy versus open total gastrectomy for cancer: a systematic review and meta-analysis. Surg Endosc. 2013 May;27(5):1509-20. doi: 10.1007/s00464-012-2661-1. Epub 2012 Dec 14.
- Background: PubMed 29218676Etoh T, Honda M, Kumamaru H, Miyata H, Yoshida K, Kodera Y, Kakeji Y, Inomata M, Konno H, Seto Y, Kitano S, Hiki N. Morbidity and mortality from a propensity score-matched, prospective cohort study of laparoscopic versus open total gastrectomy for gastric cancer: data from a nationwide web-based database. Surg Endosc. 2018 Jun;32(6):2766-2773. doi: 10.1007/s00464-017-5976-0. Epub 2017 Dec 7.
- Background: PubMed 22083338Yoon HM, Kim YW, Lee JH, Ryu KW, Eom BW, Park JY, Choi IJ, Kim CG, Lee JY, Cho SJ, Rho JY. Robot-assisted total gastrectomy is comparable with laparoscopically assisted total gastrectomy for early gastric cancer. Surg Endosc. 2012 May;26(5):1377-81. doi: 10.1007/s00464-011-2043-0. Epub 2011 Nov 16.
- Background: PubMed 24695982Son T, Lee JH, Kim YM, Kim HI, Noh SH, Hyung WJ. Robotic spleen-preserving total gastrectomy for gastric cancer: comparison with conventional laparoscopic procedure. Surg Endosc. 2014 Sep;28(9):2606-15. doi: 10.1007/s00464-014-3511-0. Epub 2014 Apr 3.
- Background: PubMed 26208497Shen W, Xi H, Wei B, Cui J, Bian S, Zhang K, Wang N, Huang X, Chen L. Robotic versus laparoscopic gastrectomy for gastric cancer: comparison of short-term surgical outcomes. Surg Endosc. 2016 Feb;30(2):574-580. doi: 10.1007/s00464-015-4241-7. Epub 2015 Jul 25.
- Background: PubMed 29211699Pan HF, Wang G, Liu J, Liu XX, Zhao K, Tang XF, Jiang ZW. Robotic Versus Laparoscopic Gastrectomy for Locally Advanced Gastric Cancer. Surg Laparosc Endosc Percutan Tech. 2017 Dec;27(6):428-433. doi: 10.1097/SLE.0000000000000469.
- Background: PubMed 24385251Junfeng Z, Yan S, Bo T, Yingxue H, Dongzhu Z, Yongliang Z, Feng Q, Peiwu Y. Robotic gastrectomy versus laparoscopic gastrectomy for gastric cancer: comparison of surgical performance and short-term outcomes. Surg Endosc. 2014 Jun;28(6):1779-87. doi: 10.1007/s00464-013-3385-6. Epub 2014 Jan 3.
- Background: PubMed 24558421Wang W, Zhang X, Shen C, Zhi X, Wang B, Xu Z. Laparoscopic versus open total gastrectomy for gastric cancer: an updated meta-analysis. PLoS One. 2014 Feb 18;9(2):e88753. doi: 10.1371/journal.pone.0088753. eCollection 2014.
- Individual participant dataSharing planned: No
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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.
Peiwu Yu, M.D. study chair
Southwest Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Southwest Hospital, China at 1 site in China.
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 7 inclusion and 13 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 21 Oct 2021. 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 China. 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.
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?
Overall postoperative morbidity and mortality (time frame: 30 days). 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 NCT03500471, which also lists 9 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 21 Oct 2021.