Gastric CancerIMIGASTRICIINCT02751086
Robotic, Laparoscopic and Open Gastrectomy Compared on Short and Long Term 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
The overall purpose is to develop and maintain a multi-institutional database comprising of information regarding surgical, clinical and oncological features of patients that will be treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Robotic Gastrectomy and Laparoscopic Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to Dec 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with gastric cancer eligible for curative surgery.
Who may be able to join
- Histologically proven gastric cancer
- Preoperative staging work-up performed by upper endoscopy and/or endoscopic ultrasound, and CT scan and in accordance to international guidelines
- Early Gastric Cancer
- Advanced Gastric Cancer
- Patients treated with curative intent in accordance to international guidelines
Who cannot join
- 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 previous abdominal surgery for gastric cancer
- Synchronous malignancy in other organs
- Palliative surgery
Trial locations and contacts
1 site in 1 country.
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: Prospective, Observational, Multicenter Study on Minimally Invasive Gastrectomy for Gastric Cancer: Robotic, Laparoscopic and Open Surgery Compared on Operative and Follow-up Outcomes
The overall purpose is to develop and maintain a multi-institutional database comprising of information regarding surgical, clinical and oncological features of patients that will be treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up.
The main objective is to compare the three surgical arms on surgical and clinical outcomes, as well as on the oncological follow-up.
Read the detailed description
A review of the scientific literature, which was recently published by the IMIGASTRIC study group, aimed to perform a more complete analysis of the current situation regarding performing minimally invasive surgery for gastric cancer. Significant limitations were found in the analyzed studies, including:
- Small samples of patients, mostly low-quality comparative studies
- Selection bias in the comparison groups (e.g. stage, extent of lymphadenectomy)
- Absence of subgroup analysis in significant research fields
- Lack of information on the surgical techniques adopted
A large prospective multicenter registry could thus be the optimal way to clarify the role of minimally invasive surgery for gastric cancer and permit the evaluation of its short and long-term effects. A working basis for analyzing outcomes of interest and obtaining directions for guidelines and future study developments can also be created. The following would be the main advantages of a large prospective multicenter registry:
- Achieving a large sample of patients
- Collecting multiple variables, allowing for the making of a comprehensive statistical report
- Standardizing the methodology to be adopted, thus increasing accuracy
- Bringing together the experiences of both East and West to discover shared points A prospective registry can become a powerful tool that can guide research in this field to new developments and pave the way for other investigational opportunities.
- Conditions
- Gastric Cancer
- Being tested
- Robotic Gastrectomy, Laparoscopic Gastrectomy
- Keywords
- minimally invasive surgery, gastrectomy, robotic surgery, laparoscopic surgery, laparoscopy, robot-assisted, robotic, robotic gastrectomy, laparoscopic gastrectomy, minimally invasive 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.
Robotic GastrectomyProcedure or surgery
Minimally invasive surgical approach, related to the availability of a robotic surgical system (eg Da Vinci surgical system), that allows a surgeon to perform surgery through a console and dedicated devices.
Laparoscopic GastrectomyProcedure or surgery
Minimally invasive surgical approach performed through traditional laparoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Gastrectomy | Patients who will be treated for gastric cancer with the assistance of the robotic surgical system Receives: Procedure: Robotic Gastrectomy | |
| Laparoscopic Gastrectomy | Patients who will be treated for gastric cancer through laparoscopic devices. Receives: Procedure: Laparoscopic Gastrectomy | |
| Open Gastrectomy | Patients who will be treated for gastric cancer with traditional open surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with intraoperative adverse events
events other than the normal course of the surgery
Measured: During surgery
Mean of retrieved lymph nodes
Count of retrieved lymph nodes at the histopathological examination of the surgical specimen
Measured: Within 30 days after surgery
Rate of patients alive
subjects alive at the planned endpoint
Measured: 1 year after surgery
Rate of patients alive
subjects alive at the planned endpoint
Measured: 2 year after surgery
Rate of patients alive
subjects alive at the planned endpoint
Measured: 3 year after surgery
Rate of patients alive
subjects alive at the planned endpoint
Measured: 4 year after surgery
Rate of patients alive
subjects alive at the planned endpoint
Measured: 5 year after surgery
Secondary outcomes (2)
Mean post-operative hospital stay
hospital stay of the patients after surgery
Measured: from the day after surgery to patient discharge, assessed up to 90 days
Rate of complications after discharge
any surgical related event after patient's discharge
Measured: 5 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2020 (estimated)
- Study completionDec 2024 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Study Group on Minimally Invasive Surgery for Gastric Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amilcare Parisi, International Study Group on Minimally Invasive Surgery for Gastric Cancer
- Investigators
- Amilcare Parisi, MD, Principal investigator, St. Mary's Hospital of Terni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751086
- Sponsor's protocol ID
- 002
- Acronym
- IMIGASTRICII
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2016
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Parisi A, Nguyen NT, Reim D, Zhang S, Jiang ZW, Brower ST, Azagra JS, Facy O, Alimoglu O, Jackson PG, Tsujimoto H, Kurokawa Y, Zang L, Coburn NG, Yu PW, Zhang B, Qi F, Coratti A, Annecchiarico M, Novotny A, Goergen M, Lequeu JB, Eren T, Leblebici M, Al-Refaie W, Takiguchi S, Ma J, Zhao YL, Liu T, Desiderio J. Current status of minimally invasive surgery for gastric cancer: A literature review to highlight studies limits. Int J Surg. 2015 May;17:34-40. doi: 10.1016/j.ijsu.2015.02.021. Epub 2015 Mar 7.
PubMed 25758348Parisi A, Desiderio J. Establishing a multi-institutional registry to compare the outcomes of robotic, laparoscopic, and open surgery for gastric cancer. Surgery. 2015 Apr;157(4):830-1. doi: 10.1016/j.surg.2014.12.007. Epub 2015 Jan 26. No abstract available.
PubMed 25633739Desiderio 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 26482769Marano 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 24156033Vinuela 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 22330034Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer. 2011 Jun;14(2):113-23. doi: 10.1007/s10120-011-0042-4. No abstract available.
PubMed 21573742Japanese Gastric Cancer Association. Japanese classification of gastric carcinoma: 3rd English edition. Gastric Cancer. 2011 Jun;14(2):101-12. doi: 10.1007/s10120-011-0041-5. No abstract available.
PubMed 21573743Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
PubMed 19638912Waddell T, Verheij M, Allum W, Cunningham D, Cervantes A, Arnold D. Gastric cancer: ESMO-ESSO-ESTRO clinical practice guidelines for diagnosis, treatment and follow-up. Eur J Surg Oncol. 2014 May;40(5):584-591. doi: 10.1016/j.ejso.2013.09.020. No abstract available.
PubMed 24685156Washington K. 7th edition of the AJCC cancer staging manual: stomach. Ann Surg Oncol. 2010 Dec;17(12):3077-9. doi: 10.1245/s10434-010-1362-z. No abstract available.
PubMed 20882416
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
- Prospective, Observational, Multicenter Study on Minimally Invasive Gastrectomy for Gastric Cancer: Robotic, Laparoscopic and Open Surgery Compared on Operative and Follow-up Outcomes
- ClinicalTrials.gov ID
- NCT02751086
- Acronym / sponsor ID
- IMIGASTRICII / 002
- Conditions
- Gastric Cancer
- Keywords
- minimally invasive surgery, gastrectomy, robotic surgery, laparoscopic surgery, laparoscopy, robot-assisted, robotic, robotic gastrectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- International Study Group on Minimally Invasive Surgery for Gastric CancerUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Apr 2016 (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 overall purpose is to develop and maintain a multi-institutional database comprising of information regarding surgical, clinical and oncological features of patients that will be treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up.
The main objective is to compare the three surgical arms on surgical and clinical outcomes, as well as on the oncological follow-up.
Detailed description
A review of the scientific literature, which was recently published by the IMIGASTRIC study group, aimed to perform a more complete analysis of the current situation regarding performing minimally invasive surgery for gastric cancer. Significant limitations were found in the analyzed studies, including:
- Small samples of patients, mostly low-quality comparative studies
- Selection bias in the comparison groups (e.g. stage, extent of lymphadenectomy)
- Absence of subgroup analysis in significant research fields
- Lack of information on the surgical techniques adopted
A large prospective multicenter registry could thus be the optimal way to clarify the role of minimally invasive surgery for gastric cancer and permit the evaluation of its short and long-term effects. A working basis for analyzing outcomes of interest and obtaining directions for guidelines and future study developments can also be created. The following would be the main advantages of a large prospective multicenter registry:
- Achieving a large sample of patients
- Collecting multiple variables, allowing for the making of a comprehensive statistical report
- Standardizing the methodology to be adopted, thus increasing accuracy
- Bringing together the experiences of both East and West to discover shared points A prospective registry can become a powerful tool that can guide research in this field to new developments and pave the way for other investigational opportunities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robotic Gastrectomy | – | Procedure: Robotic GastrectomyPatients who will be treated for gastric cancer with the assistance of the robotic surgical system |
| Laparoscopic Gastrectomy | – | Procedure: Laparoscopic GastrectomyPatients who will be treated for gastric cancer through laparoscopic devices. |
| Open Gastrectomy | – | –Patients who will be treated for gastric cancer with traditional open surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with gastric cancer eligible for curative surgery.
Key inclusion criteria (5 listed)
- Histologically proven gastric cancer
- Preoperative staging work-up performed by upper endoscopy and/or endoscopic ultrasound, and CT scan and in accordance to international guidelines
- Early Gastric Cancer
- Advanced Gastric Cancer
- Patients treated with curative intent in accordance to international guidelines
Key exclusion criteria (5 listed)
- 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 previous abdominal surgery for gastric cancer
- Synchronous malignancy in other organs
- Palliative surgery
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 GastrectomyMinimally invasive surgical approach, related to the availability of a robotic surgical system (eg Da Vinci surgical system), that allows a surgeon to perform surgery through a console and dedicated devices. | Procedure or surgery | Robotic Gastrectomy |
| Laparoscopic GastrectomyMinimally invasive surgical approach performed through traditional laparoscopy. | Procedure or surgery | Laparoscopic Gastrectomy |
Primary outcome
Rate of patients with intraoperative adverse events
Time frame: During surgery
events other than the normal course of the surgery
Mean of retrieved lymph nodes
Time frame: Within 30 days after surgery
Count of retrieved lymph nodes at the histopathological examination of the surgical specimen
Rate of patients alive
Time frame: 1 year after surgery
subjects alive at the planned endpoint
Rate of patients alive
Time frame: 2 year after surgery
subjects alive at the planned endpoint
Rate of patients alive
Time frame: 3 year after surgery
subjects alive at the planned endpoint
Rate of patients alive
Time frame: 4 year after surgery
subjects alive at the planned endpoint
Rate of patients alive
Time frame: 5 year after surgery
subjects alive at the planned endpoint
2 secondary outcomes
Mean post-operative hospital stay
Time frame: from the day after surgery to patient discharge, assessed up to 90 days
Rate of complications after discharge
Time frame: 5 year 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 25758348Parisi A, Nguyen NT, Reim D, Zhang S, Jiang ZW, Brower ST, Azagra JS, Facy O, Alimoglu O, Jackson PG, Tsujimoto H, Kurokawa Y, Zang L, Coburn NG, Yu PW, Zhang B, Qi F, Coratti A, Annecchiarico M, Novotny A, Goergen M, Lequeu JB, Eren T, Leblebici M, Al-Refaie W, Takiguchi S, Ma J, Zhao YL, Liu T, Desiderio J. Current status of minimally invasive surgery for gastric cancer: A literature review to highlight studies limits. Int J Surg. 2015 May;17:34-40. doi: 10.1016/j.ijsu.2015.02.021. Epub 2015 Mar 7.
- Background: PubMed 25633739Parisi A, Desiderio J. Establishing a multi-institutional registry to compare the outcomes of robotic, laparoscopic, and open surgery for gastric cancer. Surgery. 2015 Apr;157(4):830-1. doi: 10.1016/j.surg.2014.12.007. Epub 2015 Jan 26. No abstract available.
- Background: 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.
- 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 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 21573742Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer. 2011 Jun;14(2):113-23. doi: 10.1007/s10120-011-0042-4. No abstract available.
- Background: PubMed 21573743Japanese Gastric Cancer Association. Japanese classification of gastric carcinoma: 3rd English edition. Gastric Cancer. 2011 Jun;14(2):101-12. doi: 10.1007/s10120-011-0041-5. No abstract available.
- Background: PubMed 19638912Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
- Background: PubMed 24685156Waddell T, Verheij M, Allum W, Cunningham D, Cervantes A, Arnold D. Gastric cancer: ESMO-ESSO-ESTRO clinical practice guidelines for diagnosis, treatment and follow-up. Eur J Surg Oncol. 2014 May;40(5):584-591. doi: 10.1016/j.ejso.2013.09.020. No abstract available.
- Background: PubMed 20882416Washington K. 7th edition of the AJCC cancer staging manual: stomach. Ann Surg Oncol. 2010 Dec;17(12):3077-9. doi: 10.1245/s10434-010-1362-z. No abstract available.
- Study's website. The study is open to other interested Institutions.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
St. Mary's Hospital of 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 5 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?
Rate of patients with intraoperative adverse events (time frame: During surgery). The study lists 7 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 NCT02751086, 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 22 Apr 2019.