Robotic, Laparoscopic and Open Gastrectomy Compared on Short and Long Term Outcomes (IMIGASTRICII)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02751086 |
|
Recruitment Status :
Recruiting
First Posted : April 26, 2016
Last Update Posted : April 22, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Gastric Cancer | Procedure: Robotic Gastrectomy Procedure: Laparoscopic Gastrectomy |
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 Type : | Observational |
| Estimated Enrollment : | 5000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Study Start Date : | April 2016 |
| Estimated Primary Completion Date : | January 2020 |
| Estimated Study Completion Date : | December 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Robotic Gastrectomy
Patients who will be treated for gastric cancer with the assistance of the robotic surgical system
|
Procedure: Robotic Gastrectomy
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 Gastrectomy
Patients who will be treated for gastric cancer through laparoscopic devices.
|
Procedure: Laparoscopic Gastrectomy
Minimally invasive surgical approach performed through traditional laparoscopy. |
|
Open Gastrectomy
Patients who will be treated for gastric cancer with traditional open surgery.
|
- 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
- Mean post-operative hospital stay [ Time Frame: from the day after surgery to patient discharge, assessed up to 90 days ]hospital stay of the patients after surgery
- Rate of complications after discharge [ Time Frame: 5 year after surgery ]any surgical related event after patient's discharge
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751086
| Contact: Jacopo Desiderio, MD | +393497531121 | djdesi85@hotmail.it |
| Italy | |
| Department of Digestive Surgery, St. Mary's Hospital, University of Perugia | Recruiting |
| Terni, Italy, 05100 | |
| Contact: Amilcare Parisi amilcareparisi@virgilio.it | |
| Contact: Jacopo Desiderio djdesi85@hotmail.it | |
| Principal Investigator: | Amilcare Parisi, MD | St. Mary's Hospital of Terni |
Study Data/Documents: Study Protocol, study information, news
The study is open to other interested Institutions.
Correspondance to:
Jacopo Desiderio, MD djdesi85@hotmail.it
Publications:
| Responsible Party: | Amilcare Parisi, Principal Investigator, International Study Group on Minimally Invasive Surgery for Gastric Cancer |
| ClinicalTrials.gov Identifier: | NCT02751086 |
| Other Study ID Numbers: |
002 |
| First Posted: | April 26, 2016 Key Record Dates |
| Last Update Posted: | April 22, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
|
minimally invasive surgery gastrectomy robotic surgery laparoscopic surgery laparoscopy |
robot-assisted robotic robotic gastrectomy laparoscopic gastrectomy minimally invasive gastrectomy |
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |