Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Patients underwent gastric surgery through the use of a robotic system.

Patients underwent gastric surgery with laparoscopic procedures.

Gastrectomy performed with a robotic system.

Robot-Assisted Gastrectomy

Gastrectomy performed with conventional laparoscopic approach.

Laparoscopic Gastrectomy

Mª Asunción Acosta Mérida, MD. PhD.

In recent years there has been a rapid incursion of robotic technology applied to almost all fields of surgery. In gastric cancer, whose mainstay of treatment is still surgical resection, gastrectomy with robotic lymphadenectomy is growing faster than the scientific evidence supporting its results.

The "National Multicenter Cohort Study of ROBOT-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer" (ROBOTAG study) is proposed as a prospective multicenter Spanish nationwide study, comparing robotic gastrectomy versus conventional laparoscopic gastrectomy for the treatment of gastric cancer. This study aims to provide evidence on the feasibility, safety and complications, possible technical advantages, short and long term surgical and oncological results, as well as aspects related to quality of life, which can support the increase in cost and the important technological effort that underlies robotic surgery with respect to conventional laparoscopic access.

The relevance of this project is doubled by directing the objectives, on the one hand, on a new and expensive technology that is reaching hospitals still surrounded by controversy about its real benefits; and on the other hand, by acting on a pathology for which most of the available studies come from Eastern countries, sometimes not very applicable to the Western context.

RELEVANCE OF THE STUDY

The project presented here is a pioneering study in Spain, which aims to provide scientific evidence on robot-assisted gastrectomy in gastric cancer. The feasibility, oncologic outcomes, potential benefits, complications and limitations will be investigated. Few hospitals in the country have robotic technology and also perform this surgical procedure. The aim is to include as many centers as possible in this study, which will involve an important effort, but also the search for answers of great scientific value and repercussion in the applicability of this innovation in western environment. It is hoped to be able to provide, both at the management level of the Spanish Health System and extensively in other countries, a basis for decision making to audit and, if necessary, endorse the development and diffusion of this technology in hospitals, in order to offer patients the best surgical option in the treatment of gastric cancer.

OBJECTIVES

The main objective of this study is to compare Robot-Assisted Gastrectomy (RAG) with conventional Laparoscopic Gastrectomy (LG), from the point of view of clinical and oncological safety.

In addition, possible differences between patients undergoing each technique will be analyzed in other aspects, both intraoperatively and postoperatively.

Primary objective The main objective of this study is to compare the clinical and oncological safety of robot-assisted gastrectomy (RAG) with conventional laparoscopic gastrectomy (LG).

For this purpose the investigators will analyze in both groups (robot and laparoscopy):

1. as a measure of clinical safety:

   * Intraoperative blood loss
   * Perioperative complications
2. and as a measure of oncologic safety:

   * Nodal count (Number of lymph nodes retrieved)
   * R0 resection margin

   Secondary objectives

   To assess the differences between the groups (RAG vs LG) in intraoperative outcomes:
   * Operative time
   * Number of surgeons per procedure
   * Need for conversion to open surgery
   * Surgeon comfort
   * Learning curve

   To assess the differences between groups (RAG vs LG) in postoperative recovery course and physical status:
   * Onset of oral tolerance
   * Onset of mobilization
   * Hospital stay
   * Readmission
   * Mortality.

   To assess the differences between groups (RAG vs LG) in oncological outcomes:
   * Overall and disease-free survival
   * Local and systemic recurrence To assess the differences between the groups (RAG vs LG) cost utility measured in QALYs.

   HYPOTHESIS

   Robot-assisted laparoscopic gastrectomy with lymphadenectomy (RAG) offers at least the same results as gastrectomy with lymphadenectomy using a conventional laparoscopic (LG) approach in the treatment of gastric cancer, in terms of feasibility, safety, complications, and oncological outcomes.

   MATERIAL AND METHODS
   * Type of study: National, multicenter, prospective follow-up cohort study in patients undergoing minimally invasive gastric cancer surgery, using robot-assisted laparoscopic gastrectomy with lymphadenectomy (RAG) versus conventional laparoscopy (LG).
   * Study population: Patients diagnosed with gastric adenocarcinoma, in whom surgical treatment with curative intent by minimally invasive gastrectomy (RAG or LG) has been indicated.

   The protocol will follow standard clinical practice, without being modified by the present study.

   Patients who agree to participate in the study will have signed the informed consent form.

   • Primary outcome variable:
   * As a clinical safety measure, intraoperative blood loss and perioperative complications at 30 and 90 days will be analyzed.
   * As an oncological safety measure, the number of resected lymph nodes and the R0 resection margin will be analyzed.
   * Other intraoperative and postoperative, oncologic and quality of life parameters will be analyzed secondarily.

     * Sample size:

   This study aims to involve the largest number of centers nationwide and recruit the largest possible number of patients that these centers can provide. Taking into account the annual incidence of cases in each center, an approximate number of 20 cases per year per center is estimated. With the participation of at least 20 hospital centers, the investigators hope to obtain a sample of at least 400 patients for analysis.
   * Inclusion criteria:

     - Histologically confirmed primary gastric adenocarcinoma

     - Clinical stages Ib, II and III of gastric cancer (8th edition of the TNM classification)

     - Patients with ECOG performance status 0, 1 or 2

     - Patients who sign the informed consent to participate in the study

     - Patients over 18 years old

     - Patients treated by surgery with curative intent
   * Exclusion criteria:

     - Any histology other than adenocarcinoma

     - Stage Ia and IV

     - Unresectability criteria (tumor factors): distant metastasis, peritoneal carcinomatosis, positive cytology of ascitic fluid, invasion or tumor entrapment of large vessels (aorta, liver, celiac trunk), infiltration of the root of the mesentery, para-aortic lymphadenopathy or levels \>3, linitis plastica, involvement of other organs

     - Inoperability criteria (patient factors): serious concomitant systemic disorders incompatible with surgery or the study (at the discretion of the investigator)

     - Non-compliance with any of the inclusion criteria
     * Patients undergoing surgery for gastric cancer with open approach at the beginning
     * Palliative surgery cases
   * Recruitment:

   All the centers included in the study must have the human and technical means necessary to guarantee the quality of the surgical treatment of gastric cancer, following current standards.

   The surgery will be performed in a hospital that has a specialized Esophagogastric Surgery Unit that performs advanced minimally invasive, laparoscopic and robotic surgery on a regular basis, as well as a Multidisciplinary Tumor Committee.

   All surgeons included must have previous experience of at least 20 gastrectomies with laparoscopic lymphadenectomies and an annual caseload of at least 10 cases; in addition to having accreditation as a robot console surgeon, having previously performed at least 3 gastrectomies with robot-assisted oncologic lymphadenectomy.

   Patients who are candidates for inclusion by the participating centers, who meet the inclusion criteria and who wish to participate, must sign the informed consent for the study. Access codes will be assigned to the center's investigators for the anonymized introduction of the study data. The confidentiality of the information handling of this study will be guaranteed, following national and international regulations.

   • Duration of study: Each collaborating researcher will provide patients who meet the inclusion criteria, recruiting them for 1 year. The minimum follow-up of all patients will be 1 year, after which the global analysis of the data and the corresponding study will be carried out. The final objective would be to achieve follow-up of all patients for at least 5 years, after which a new global analysis of the sample would be carried out to obtain the results after this period.

   • Follow-up: All patients included in the study must have at least a 1-year follow-up.

   The study will end when all enrolled patients have been followed for five years, died, withdrew consent or were lost to follow-up. A preliminary analysis of results will be performed when all patients enrolled in the study have been followed for the first year.

   • Data collection:

   In this study it is planned to obtain information from the collection of preoperative, intraoperative and postoperative data:

   - Patient's affiliation data

   - Medical history

   - Analytical and complementary test data

   - Patient and tumor characteristics

   - Surgical procedure parameters
   * Postoperative results
   * Follow-up data and quality of life

   The patient will be followed up throughout the study, and the status of the postoperative variables will be collected at each medical appointment.

   • Statistical analysis: Descriptive analysis of the data will be performed. Qualitative variables will be presented by frequency distribution and quantitative variables will be measured by indicators of central tendency (mean or median) and dispersion (standard deviation or interquartile range, respectively).

   Hypothesis contrast tests will be performed, with comparison of proportions when both variables are qualitative (Chi-square, Fisher's exact test) and comparisons of means for independent samples when one of them is quantitative (Student's t test if normal distribution or Mann-Whitney U test for variables that do not comply with normality). Survival will be estimated using the Kaplan-Meier method and survival curves will be compared using the Log-Rank test to analyze the effect of the different factors that may influence survival. The results of the study will be analyzed by intention-to-treat. After recruitment of half of the patients, an intermediate data analysis will be performed.

   The final analysis will be performed in two phases, one on the morbidity-mortality results at the end of recruitment, and another at the end of the study with the definitive data on recurrence and survival.

   A logistic regression model will be performed to evaluate the effect of representative covariates on the LRS. For this purpose, those that are significant in the univariate analysis (p\<0.2) or clinically relevant will be included.

   A value of p\<0.05 will be considered statistically significant.

National Multicenter Cohort Study of Robot-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer

Intraoperative blood loss and perioperative complications (types of complications, Clavien Dindo classification, Comprehensive Complication Index (CCI®))

Nodal count (number of lymph nodes retrieved) and R0 resection margin.

* Operative time (duration of the surgical procedure measured in minutes)
* Number of surgeons who have participated in the operation (1 to 5)
* Need for conversion to open surgery (conversion to open surgery vs non-conversion)
* Comfort of the surgeon during the intervention, using an analog scale of 0-5 (0 is no comfort, 1 is little comfort, 2 is moderate comfort, 3 is quite a bit of comfort, 4 is a lot of comfort and 5 is extreme comfort)
* Learning curve (number of robotic versus laparoscopic gastrectomies performed by the surgeon before the registered case)

* Onset of oral tolerance (measured in number of days from the intervention to the first oral intake)
* Onset of mobilization (measured in number of days from the operation to the start of the patient's ambulation)
* Hospital stay (number of days of hospital admission, counted from the day of the intervention until discharge)
* Readmission (yes /no) (need for hospital admission after discharge, related to the operation, over 1 year postoperatively)
* Mortality (yes /no) (procedure-related death, within 1 year postoperatively) In case of death: time in days since surgery.

* Overall survival (OS): time between the date of intervention and the date of death (from any cause).
* Recurrence-free survival (RFS): time from the date of intervention to locoregional recurrence, distant recurrence or death, whichever occurred first. The date of biopsy will be the date of recurrence (or date of death).
* Local recurrence: surgical site of gastrectomy and lymphadenectomy (anastomosis or perianastomosis nodes).
* Distant or systemic recurrence: extra-regional lymph nodes (N3 and/or more distant lymph node levels), metastases in laparoscopic ports, parenchymal organ, carcinomatosis or bone metastases.

Dr. Negrin University Hospital

Principal Investigator

Patients underwent gastric surgery with open approach.

Surgical procedure performed with a robotic system.

Robotic Surgery

Surgical procedure performed with laparoscopic techniques.

Laparoscopic Surgery

Open Surgery

Jacopo Desiderio, MD

Amilcare Parisi, MD

Amilcare Parisi

Jacopo Desiderio

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.

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.

Robotic, Laparoscopic and Open Surgery for Gastric Cancer Compared on Surgical, Clinical and Oncological Outcomes

A Multi-Institutional Chart Review to Compare the Outcomes of Robotic, Laparoscopic and Open Surgery for Gastric Cancer.

Days of hospitalization after surgery until discharge.

Score based on the Clavien-Dindo classification system.

Fondazione CARIT

LOGIX S.r.l.

International Study Group on Minimally Invasive Surgery for Gastric Cancer

After exploration and randomization, patients received total robotic distal gastrectomy

After exploration and randomization, patients received robotic-assisted distal gastrectomy.

All the surgical procedures are performed using the robot system.

Total Robotic Distal Gastrectomy

After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.

Robotic-Assisted Distal Gastrectomy

Chang-ming Huang, MD

Qi-yue Chen, PhD

Changming Huang, M.D., Ph.D.

To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, M0).

In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether total robotic gastrectomy is noninferior to robotic-assisted gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of total robotic versus robotic assisted distal gastrectomy for GC.

Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.

Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.

The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.

Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher

Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status.

The variation of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response

From the beginning to the end of digestive tract reconstruction

Fujian Medical University

Professor

Symptoms and General Pathology

Behaviors and Mental Disorders

Inflammation

Quality of Life

Acute Graft Versus Host Disease

Minimally invasive surgery revolutionized the field of gastric cancer surgery. The surgical robot was introduced to alleviate the difficulty of laparoscopic surgery. Although many studies have reported successful outcomes for robotic surgery, there is no multicenter prospective analysis regarding the advantage of the robotic gastrectomy. The aim of this study is to analyze the surgical outcomes of the robotic gastrectomy focusing on the learning curve, cost-effectiveness, quality of life, and acute-inflammatory reaction in comparison with laparoscopic gastrectomy.

Multi-institutional Study on the Assessment of Robotic Surgery for Gastric Cancer

Yonsei University

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Dexmedetomidine

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum.

dexmedetomidine

saline

Na Young Kim, MD

Many studies have shown that inflammation has an important effect on the development, progression, and also response to treatment of tumors. Dexmedetomidine is a potent and selective alpha 2 receptor agonist, known to have a sedative, analgesic and immune-controlling effect. The purpose of this study is to investigate the effect of dexmedetomidine during surgery on postoperative inflammatory response and surgical recovery in gastric cancer patients undergoing robot or laparoscopic gastrectomy.

* Experimental group (Dexmedetomidine group) Continuous IV Precedex™ using infusion pump (Terufusion TE-311, Terumo, Tokyo, Japan) during surgery (from immediately after induction to before starting peritoneum closure) Infusion rate 0.4μg/kg/hr
* Control group (normal saline group) Continuous IV normal saline using infusion pump (Terufusion TE-311, Terumo, Tokyo, Japan) during surgery Infusion rate 0.4μg/kg/hr

Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation

The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy

The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy; Double Blind Randomized Controlled Trial

To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.

To evaluate the effect of dexmedetomidine on the level of cytokine in patients undergoing robot or laparoscopic gastrectomy, cytokine level was measured 7 times above time points using ELISA analysis.

To evaluate the effect of dexmedetomidine on the level of WBC in patients undergoing robot or laparoscopic gastrectomy, WBC level was measured 7 times above time points.

To evaluate the effect of dexmedetomidine on score of postoperative pain in patients undergoing robot or laparoscopic gastrectomy, NRS was measured during postoperative 48 hours.

To evaluate the effect of dexmedetomidine on postoperative any unwanted admission in patients undergoing robot or laparoscopic gastrectomy, postoperative any unwanted admission was checked during postoperative 1 month.

To evaluate the effect of dexmedetomidine on gas passing in patients undergoing robot or laparoscopic gastrectomy, gas passing out time was checked.

To evaluate the effect of dexmedetomidine on hospital day (HOD) in patients undergoing robot or laparoscopic gastrectomy, discharge day was checked.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
National Multicenter Cohort Study of Robot-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer	NCT06242613	Gastric Cancer	Robot-Assisted ... Laparoscopic Ga...	18 Years -	Dr. Negrin University Hospital
Robotic, Laparoscopic and Open Surgery for Gastric Cancer Compared on Surgical, Clinical and Oncological Outcomes	NCT02325453	Gastric Cancer	Robotic Surgery Laparoscopic Su... Open Surgery	-	International Study Group on Minimally Invasive Surgery for Gastric Cancer
National Multicenter Cohort Study of Robot-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer	NCT06242613	Gastric Cancer	Robot-Assisted ... Laparoscopic Ga...	18 Years -	Dr. Negrin University Hospital
Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer	NCT04795063	Gastric Cancer Robotic Gastrec...	Total Robotic D... Robotic-Assiste...	18 Years - 75 Years	Fujian Medical University
Multi-institutional Study on the Assessment of Robotic Surgery for Gastric Cancer	NCT01309256	Gastric Cancer		20 Years -	Yonsei University
Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer	NCT04795063	Gastric Cancer Robotic Gastrec...	Total Robotic D... Robotic-Assiste...	18 Years - 75 Years	Fujian Medical University
The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy	NCT03960775	Gastric Cancer Gastrostomy	dexmedetomidine saline	20 Years - 70 Years	Yonsei University

Spots Global Cancer Trial Database for robotic gastrectomy