Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Gastrectomy | Patients who will be treated for gastric cancer with the assistance of the robotic surgical system |
| |
| Laparoscopic Gastrectomy | Patients who will be treated for gastric cancer through laparoscopic devices. |
| |
| Open Gastrectomy | Patients who will be treated for gastric cancer with traditional open surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Gastrectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with intraoperative adverse events | events other than the normal course of the surgery | During surgery |
| Mean of retrieved lymph nodes | Count of retrieved lymph nodes at the histopathological examination of the surgical specimen | Within 30 days after surgery |
| Rate of patients alive | subjects alive at the planned endpoint | 1 year after surgery |
| Rate of patients alive | subjects alive at the planned endpoint | 2 year after surgery |
| Rate of patients alive | subjects alive at the planned endpoint | 3 year after surgery |
| Rate of patients alive | subjects alive at the planned endpoint | 4 year after surgery |
| Rate of patients alive | subjects alive at the planned endpoint | 5 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mean post-operative hospital stay | hospital stay of the patients after surgery | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Subjects with gastric cancer eligible for curative surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacopo Desiderio, MD | Contact | +393497531121 | djdesi85@hotmail.it |
| Name | Affiliation | Role |
|---|---|---|
| Amilcare Parisi, MD | St. Mary's Hospital of Terni | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Digestive Surgery, St. Mary's Hospital, University of Perugia | Recruiting | Terni | 05100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25758348 | Background | 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. | |
| 25633739 |
| Label | URL |
|---|---|
| Study's website. The study is open to other interested Institutions. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol, study information, news | View IPD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Laparoscopic Gastrectomy | Procedure | Minimally invasive surgical approach performed through traditional laparoscopy. |
|
| 5 year after surgery |
| Background |
| Parisi 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. |
| 26482769 | Background | Desiderio 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. |
| 24156033 | Background | Marano 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. |
| 22330034 | Background | 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. |
| 21573742 | Background | Japanese 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. |
| 21573743 | Background | Japanese 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. |
| 19638912 | Background | Clavien 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. |
| 24685156 | Background | Waddell 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. |
| 20882416 | Background | Washington 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. |
The study is open to other interested Institutions. Correspondance to: Jacopo Desiderio, MD djdesi85@hotmail.it |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |