Gastric CancerNCT02325453
Robotic, Laparoscopic and Open Surgery for Gastric Cancer Compared on Surgical, Clinical and Oncological Outcomes
An observational study of Gastric Cancer, run by International Study Group on Minimally Invasive Surgery for Gastric Cancer at 1 site in Italy.
Trial summary
Gastric cancer represents a great challenge for health care providers and requires a multidisciplinary context in which surgery plays a main role. Minimally invasive surgery has been progressively developed, first with the advent of laparoscopy and more recently with the spread of robotic systems, but a number of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Robotic Surgery, Laparoscopic Surgery and Open Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 7,000 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to Jan 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects undergoing surgery for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up.
Who may be able to join
- Histologically proven gastric cancer
- Preoperative staging work-up performed by upper endoscopy / endoscopic ultrasound, and CT scan
- Early Gastric Cancer
- Advanced Gastric Cancer
- Patients treated with curative intent in accordance to international guidelines
Who cannot join
- Locally advanced tumor infiltrating neighboring organs
- Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, Krukenberg tumors, involvement of other organs
- Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score ≥4.
- History of gastric surgery
- Remnant gastric cancer
- Synchronous other major abdominal surgery
- Synchronous malignancy in other organs
- Palliative surgery cases
Trial locations and contacts
1 site in 1 country.
Amilcare Parisi, MD contact
Italy1 site, 1 recruiting
- Recruiting
Department of Digestive Surgery, St. Mary's Hospital, University of Perugia
Terni, 05100
Amilcare Parisi, amilcareparisi@virgilio.it
Jacopo Desiderio, djdesi85@hotmail.it
About this study
Official title: A Multi-Institutional Chart Review to Compare the Outcomes of Robotic, Laparoscopic and Open Surgery for Gastric Cancer.
Gastric cancer represents a great challenge for health care providers and requires a multidisciplinary context in which surgery plays a main role.
Minimally invasive surgery has been progressively developed, first with the advent of laparoscopy and more recently with the spread of robotic systems, but a number of issues are currently being debated, including the limitations in performing effective extended lymph node dissections and, in this context, the real advantages of using the robotic systems, the possible role for the Advanced Gastric Cancer, the reproducibility of completely intracorporeal techniques and the oncological results achievable during follow-up.
A multicenter study with a large number of patients is now needed to further investigate the safety and efficacy as well as long-term outcomes of robotic surgery, traditional laparoscopy and the open approach.
Read the detailed description
Overall purpose:
The Overall purpose is to develop a multi-institutional database comprising information regarding surgical, clinical and oncological features of patients undergoing surgery for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up at participating centers.
General study design:
The registry will be established by retrospectively identifying subjects with gastric cancer treated at the participating centers.
Information gathered will be obtained from existing data and records, diagnostic tests and surgical interventions.
Information will be collected and recorded by all institutes through a specific online shared system.
Main objectives:
- To determine the surgical, clinical, and oncological outcomes in both the short and long term
- To compare results according to the type of intervention, device used and manner of execution of different surgical phases
- To relate results of different surgeries with baseline characteristics of patients and stage of disease
Clinical relevance:
Studies that reported results of minimally invasive surgery for gastric cancer and recent meta-analysis emphasize the need for large trials.
A further consideration in this field regards the need of numerous patients to reach a statistical significance on surgical, clinical and oncological outcomes, in order to fully assess the effectiveness and the differences between the different surgical approaches.
At present, a multicenter registry may represent the best research tool to assess the role of minimally invasive approaches by comparing the methods with traditional open surgery.
Therefore, for this project, a large registry will be created by collecting data from the different participating centers to create a working basis for analyzing outcomes of interest and obtaining directions for further investigation.
The data collected will clarify the role of laparoscopic and robotic surgery versus the open approach in terms of:
- safety and feasibility based on the intraoperative outcomes
- respect of oncological principles in relation to the stage and location of the tumor
- recovery of gastrointestinal function considering the outcomes measured during the postoperative hospital stay
- incidence, types and severity of postoperative complications
- overall survival and disease-free survival
Duration of study:
The beginning of the trial is scheduled for January 2015. It is expected to end the chart review within one year.
Type of data collection:
In the present study, the following information will be collected:
- Patient Demographics
- Surgical Procedure details
- Tumor characteristics
- Operative findings
- Post-operative clinical findings
- Post-operative complications
- Follow-up details
Statistical analysis:
The dichotomous variables will be expressed as numbers and percentages, while continuous variables will be expressed as mean and standard deviation (SD) or median and interquartile range (minimum and maximum values).
Continuous variables, will be compared using one-way ANOVA with post hoc multiple comparison by Tukey's procedure. Pearson's χ2 test or Fisher's exact test, as appropriate, will be used for analysis of categorical data.
For each of these tests a value of alpha (α) < 0.05 will be considered statistically significant.
Potential risks and safety management:
Participation in the research registry involves the potential risks of a breach of confidentiality of the medical record information and associated privacy of the participants.
Such risks will be minimized by the use and the establishment of appropriate information technology services.
- Conditions
- Gastric Cancer
- Being tested
- Robotic Surgery, Laparoscopic Surgery, Open Surgery
- Keywords
- Robotic Surgery, Laparoscopic Surgery, Minimally Invasive Surgery, Robotic Gastrectomy, Laparoscopic Gastrectomy, Open Gastrectomy, Gastric Surgery
- 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 SurgeryProcedure or surgery
Surgical procedure performed with a robotic system.
Laparoscopic SurgeryProcedure or surgery
Surgical procedure performed with laparoscopic techniques.
Open SurgeryProcedure or surgery
Traditional approach for gastric cancer.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Surgery | Patients underwent gastric surgery through the use of a robotic system. Receives: Procedure: Robotic Surgery | |
| Laparoscopic Surgery | Patients underwent gastric surgery with laparoscopic procedures. Receives: Procedure: Laparoscopic Surgery | |
| Open Surgery | Patients underwent gastric surgery with open approach. Receives: Procedure: Open Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare robotic and laparoscopic surgery with the open approach in terms of safety and feasibility. (Intraoperative complications.)
Intraoperative complications.
Measured: Intraoperative.
Verify the respect of oncological principles through minimally invasive approaches in relation to the stage and location of the tumor by comparing results with open surgery. (Number of lymph nodes retrieved.)
Number of lymph nodes retrieved.
Measured: Intraoperative.
Compare the three treatment arms in terms of recovery of gastrointestinal functions and physical status allowing the discharge of the patient. (Days of hospitalization after surgery until discharge.)
Days of hospitalization after surgery until discharge.
Measured: Assessment during an average period of 10 days after surgery.
Compare the incidence, types and severity of early postoperative complications after gastrectomy by the three approaches. (Score based on the Clavien-Dindo classification system.)
Score based on the Clavien-Dindo classification system.
Measured: Assessment during an average period of 10 days after surgery.
Verify whether minimally invasive approaches ensure the same effectiveness than open surgery. (Overall survival.)
Overall survival.
Measured: Assessment at 1, 3, 5 years from surgery.
Compare the three treatment arms in terms of tumor recurrence after treatment. (Disease-free survival)
Disease-free survival.
Measured: Assessment at 1, 3, 5 years from surgery.
Secondary outcomes (3)
Verify the safety of intracorporeal anastomosis in comparison with extracorporeal anastomosis. (Anastomotic leakage)
Anastomotic leakage.
Measured: Assessment during an average period of 10 days after surgery.
Compare the intracorporeal anastomosis with the extracorporeal anastomosis to evaluate post-operative recovery. (Days of hospitalization after surgery until discharge.)
Days of hospitalization after surgery until discharge.
Measured: Assessment during an average period of 10 days after surgery.
Verify whether robotic gastrectomy, compared with laparoscopic or open techniques, is capable of improving postoperative surgical stress. (Granulocyte-to-lymphocyte ratio.)
Granulocyte-to-lymphocyte ratio.
Measured: Assessment during an average period of 10 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startMay 2015
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Other
- Time perspective
- Retrospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Study Group on Minimally Invasive Surgery for Gastric Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione CARIT, LOGIX S.r.l.
- Responsible party
- Principal investigator, Amilcare Parisi, Azienda Ospedaliera Santa Maria, Terni, Italy
- Investigators
- Amilcare Parisi, MD, Principal investigator, Azienda Ospedaliera S. Maria di Terni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325453
- Sponsor's protocol ID
- 001
- Status last verified
- Apr 2019
- First submitted
- 16 Dec 2014
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Vinuela EF, Gonen M, Brennan MF, Coit DG, Strong VE. Laparoscopic versus open distal gastrectomy for gastric cancer: a meta-analysis of randomized controlled trials and high-quality nonrandomized studies. Ann Surg. 2012 Mar;255(3):446-56. doi: 10.1097/SLA.0b013e31824682f4.
PubMed 22330034Alimoglu O, Atak I, Eren T. Robot-assisted laparoscopic (RAL) surgery for gastric cancer. Int J Med Robot. 2014 Sep;10(3):257-62. doi: 10.1002/rcs.1566. Epub 2013 Dec 23.
PubMed 24375986Shen WS, Xi HQ, Chen L, Wei B. A meta-analysis of robotic versus laparoscopic gastrectomy for gastric cancer. Surg Endosc. 2014 Oct;28(10):2795-802. doi: 10.1007/s00464-014-3547-1. Epub 2014 May 2.
PubMed 24789136Marano A, Choi YY, Hyung WJ, Kim YM, Kim J, Noh SH. Robotic versus Laparoscopic versus Open Gastrectomy: A Meta-Analysis. J Gastric Cancer. 2013 Sep;13(3):136-48. doi: 10.5230/jgc.2013.13.3.136. Epub 2013 Sep 30.
PubMed 24156033Liao G, Chen J, Ren C, Li R, Du S, Xie G, Deng H, Yang K, Yuan Y. Robotic versus open gastrectomy for gastric cancer: a meta-analysis. PLoS One. 2013 Dec 3;8(12):e81946. doi: 10.1371/journal.pone.0081946. eCollection 2013.
PubMed 24312610Hyun MH, Lee CH, Kim HJ, Tong Y, Park SS. Systematic review and meta-analysis of robotic surgery compared with conventional laparoscopic and open resections for gastric carcinoma. Br J Surg. 2013 Nov;100(12):1566-78. doi: 10.1002/bjs.9242.
PubMed 24264778Desiderio J, Jiang ZW, Nguyen NT, Zhang S, Reim D, Alimoglu O, Azagra JS, Yu PW, Coburn NG, Qi F, Jackson PG, Zang L, Brower ST, Kurokawa Y, Facy O, Tsujimoto H, Coratti A, Annecchiarico M, Bazzocchi F, Avanzolini A, Gagniere J, Pezet D, Cianchi F, Badii B, Novotny A, Eren T, Leblebici M, Goergen M, Zhang B, Zhao YL, Liu T, Al-Refaie W, Ma J, Takiguchi S, Lequeu JB, Trastulli S, Parisi A. Robotic, laparoscopic and open surgery for gastric cancer compared on surgical, clinical and oncological outcomes: a multi-institutional chart review. A study protocol of the International study group on Minimally Invasive surgery for GASTRIc Cancer-IMIGASTRIC. BMJ Open. 2015 Oct 19;5(10):e008198. doi: 10.1136/bmjopen-2015-008198.
PubMed 26482769
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Institutional Chart Review to Compare the Outcomes of Robotic, Laparoscopic and Open Surgery for Gastric Cancer.
- ClinicalTrials.gov ID
- NCT02325453
- Acronym / sponsor ID
- 001
- Conditions
- Gastric Cancer
- Keywords
- Robotic Surgery, Laparoscopic Surgery, Minimally Invasive Surgery, Robotic Gastrectomy, Laparoscopic Gastrectomy, Open Gastrectomy, Gastric Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- International Study Group on Minimally Invasive Surgery for Gastric CancerUniversity, hospital or other
- Collaborators
- Fondazione CARIT, LOGIX S.r.l.
- Study start
- May 2015
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 25 Dec 2014 (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.
Gastric cancer represents a great challenge for health care providers and requires a multidisciplinary context in which surgery plays a main role.
Minimally invasive surgery has been progressively developed, first with the advent of laparoscopy and more recently with the spread of robotic systems, but a number of issues are currently being debated, including the limitations in performing effective extended lymph node dissections and, in this context, the real advantages of using the robotic systems, the possible role for the Advanced Gastric Cancer, the reproducibility of completely intracorporeal techniques and the oncological results achievable during follow-up.
A multicenter study with a large number of patients is now needed to further investigate the safety and efficacy as well as long-term outcomes of robotic surgery, traditional laparoscopy and the open approach.
Detailed description
Overall purpose:
The Overall purpose is to develop a multi-institutional database comprising information regarding surgical, clinical and oncological features of patients undergoing surgery for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up at participating centers.
General study design:
The registry will be established by retrospectively identifying subjects with gastric cancer treated at the participating centers.
Information gathered will be obtained from existing data and records, diagnostic tests and surgical interventions.
Information will be collected and recorded by all institutes through a specific online shared system.
Main objectives:
- To determine the surgical, clinical, and oncological outcomes in both the short and long term
- To compare results according to the type of intervention, device used and manner of execution of different surgical phases
- To relate results of different surgeries with baseline characteristics of patients and stage of disease
Clinical relevance:
Studies that reported results of minimally invasive surgery for gastric cancer and recent meta-analysis emphasize the need for large trials.
A further consideration in this field regards the need of numerous patients to reach a statistical significance on surgical, clinical and oncological outcomes, in order to fully assess the effectiveness and the differences between the different surgical approaches.
At present, a multicenter registry may represent the best research tool to assess the role of minimally invasive approaches by comparing the methods with traditional open surgery.
Therefore, for this project, a large registry will be created by collecting data from the different participating centers to create a working basis for analyzing outcomes of interest and obtaining directions for further investigation.
The data collected will clarify the role of laparoscopic and robotic surgery versus the open approach in terms of:
- safety and feasibility based on the intraoperative outcomes
- respect of oncological principles in relation to the stage and location of the tumor
- recovery of gastrointestinal function considering the outcomes measured during the postoperative hospital stay
- incidence, types and severity of postoperative complications
- overall survival and disease-free survival
Duration of study:
The beginning of the trial is scheduled for January 2015. It is expected to end the chart review within one year.
Type of data collection:
In the present study, the following information will be collected:
- Patient Demographics
- Surgical Procedure details
- Tumor characteristics
- Operative findings
- Post-operative clinical findings
- Post-operative complications
- Follow-up details
Statistical analysis:
The dichotomous variables will be expressed as numbers and percentages, while continuous variables will be expressed as mean and standard deviation (SD) or median and interquartile range (minimum and maximum values).
Continuous variables, will be compared using one-way ANOVA with post hoc multiple comparison by Tukey's procedure. Pearson's χ2 test or Fisher's exact test, as appropriate, will be used for analysis of categorical data.
For each of these tests a value of alpha (α) < 0.05 will be considered statistically significant.
Potential risks and safety management:
Participation in the research registry involves the potential risks of a breach of confidentiality of the medical record information and associated privacy of the participants.
Such risks will be minimized by the use and the establishment of appropriate information technology services.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robotic Surgery | – | Procedure: Robotic SurgeryPatients underwent gastric surgery through the use of a robotic system. |
| Laparoscopic Surgery | – | Procedure: Laparoscopic SurgeryPatients underwent gastric surgery with laparoscopic procedures. |
| Open Surgery | – | Procedure: Open SurgeryPatients underwent gastric surgery with open approach. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects undergoing surgery for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up.
Key inclusion criteria (5 listed)
- Histologically proven gastric cancer
- Preoperative staging work-up performed by upper endoscopy / endoscopic ultrasound, and CT scan
- Early Gastric Cancer
- Advanced Gastric Cancer
- Patients treated with curative intent in accordance to international guidelines
Key exclusion criteria (8 listed)
- Locally advanced tumor infiltrating neighboring organs
- Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, Krukenberg tumors, involvement of other organs
- Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score ≥4.
- History of gastric surgery
- Remnant gastric cancer
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 SurgerySurgical procedure performed with a robotic system. | Procedure or surgery | Robotic Surgery |
| Laparoscopic SurgerySurgical procedure performed with laparoscopic techniques. | Procedure or surgery | Laparoscopic Surgery |
| Open SurgeryTraditional approach for gastric cancer. | Procedure or surgery | Open Surgery |
Primary outcome
Compare robotic and laparoscopic surgery with the open approach in terms of safety and feasibility. (Intraoperative complications.)
Time frame: Intraoperative.
Intraoperative complications.
Verify the respect of oncological principles through minimally invasive approaches in relation to the stage and location of the tumor by comparing results with open surgery. (Number of lymph nodes retrieved.)
Time frame: Intraoperative.
Number of lymph nodes retrieved.
Compare the three treatment arms in terms of recovery of gastrointestinal functions and physical status allowing the discharge of the patient. (Days of hospitalization after surgery until discharge.)
Time frame: Assessment during an average period of 10 days after surgery.
Days of hospitalization after surgery until discharge.
Compare the incidence, types and severity of early postoperative complications after gastrectomy by the three approaches. (Score based on the Clavien-Dindo classification system.)
Time frame: Assessment during an average period of 10 days after surgery.
Score based on the Clavien-Dindo classification system.
Verify whether minimally invasive approaches ensure the same effectiveness than open surgery. (Overall survival.)
Time frame: Assessment at 1, 3, 5 years from surgery.
Overall survival.
Compare the three treatment arms in terms of tumor recurrence after treatment. (Disease-free survival)
Time frame: Assessment at 1, 3, 5 years from surgery.
Disease-free survival.
3 secondary outcomes
Verify the safety of intracorporeal anastomosis in comparison with extracorporeal anastomosis. (Anastomotic leakage)
Time frame: Assessment during an average period of 10 days after surgery.
Compare the intracorporeal anastomosis with the extracorporeal anastomosis to evaluate post-operative recovery. (Days of hospitalization after surgery until discharge.)
Time frame: Assessment during an average period of 10 days after surgery.
Verify whether robotic gastrectomy, compared with laparoscopic or open techniques, is capable of improving postoperative surgical stress. (Granulocyte-to-lymphocyte ratio.)
Time frame: Assessment during an average period of 10 days after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Background: PubMed 22330034Vinuela EF, Gonen M, Brennan MF, Coit DG, Strong VE. Laparoscopic versus open distal gastrectomy for gastric cancer: a meta-analysis of randomized controlled trials and high-quality nonrandomized studies. Ann Surg. 2012 Mar;255(3):446-56. doi: 10.1097/SLA.0b013e31824682f4.
- Background: PubMed 24375986Alimoglu O, Atak I, Eren T. Robot-assisted laparoscopic (RAL) surgery for gastric cancer. Int J Med Robot. 2014 Sep;10(3):257-62. doi: 10.1002/rcs.1566. Epub 2013 Dec 23.
- Background: PubMed 24789136Shen WS, Xi HQ, Chen L, Wei B. A meta-analysis of robotic versus laparoscopic gastrectomy for gastric cancer. Surg Endosc. 2014 Oct;28(10):2795-802. doi: 10.1007/s00464-014-3547-1. Epub 2014 May 2.
- Background: PubMed 24156033Marano A, Choi YY, Hyung WJ, Kim YM, Kim J, Noh SH. Robotic versus Laparoscopic versus Open Gastrectomy: A Meta-Analysis. J Gastric Cancer. 2013 Sep;13(3):136-48. doi: 10.5230/jgc.2013.13.3.136. Epub 2013 Sep 30.
- Background: PubMed 24312610Liao G, Chen J, Ren C, Li R, Du S, Xie G, Deng H, Yang K, Yuan Y. Robotic versus open gastrectomy for gastric cancer: a meta-analysis. PLoS One. 2013 Dec 3;8(12):e81946. doi: 10.1371/journal.pone.0081946. eCollection 2013.
- Background: PubMed 24264778Hyun MH, Lee CH, Kim HJ, Tong Y, Park SS. Systematic review and meta-analysis of robotic surgery compared with conventional laparoscopic and open resections for gastric carcinoma. Br J Surg. 2013 Nov;100(12):1566-78. doi: 10.1002/bjs.9242.
- Derived from this study: PubMed 26482769Desiderio J, Jiang ZW, Nguyen NT, Zhang S, Reim D, Alimoglu O, Azagra JS, Yu PW, Coburn NG, Qi F, Jackson PG, Zang L, Brower ST, Kurokawa Y, Facy O, Tsujimoto H, Coratti A, Annecchiarico M, Bazzocchi F, Avanzolini A, Gagniere J, Pezet D, Cianchi F, Badii B, Novotny A, Eren T, Leblebici M, Goergen M, Zhang B, Zhao YL, Liu T, Al-Refaie W, Ma J, Takiguchi S, Lequeu JB, Trastulli S, Parisi A. Robotic, laparoscopic and open surgery for gastric cancer compared on surgical, clinical and oncological outcomes: a multi-institutional chart review. A study protocol of the International study group on Minimally Invasive surgery for GASTRIc Cancer-IMIGASTRIC. BMJ Open. 2015 Oct 19;5(10):e008198. doi: 10.1136/bmjopen-2015-008198.
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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.
Amilcare Parisi, MD contact
Amilcare Parisi, MD principal investigator
Azienda Ospedaliera S. Maria di Terni
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 International Study Group on Minimally Invasive Surgery for Gastric Cancer at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 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 22 Apr 2019. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacopo Desiderio, MD (+393497531121, djdesi85@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare robotic and laparoscopic surgery with the open approach in terms of safety and feasibility. (Intraoperative complications.) (time frame: Intraoperative.). The study lists 6 primary outcomes in all. 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 NCT02325453, which also lists 7 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 22 Apr 2019.