Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Stomach Cancer

Other Dietary Supplements

All Drugs and Chemicals

Omega 3 Fatty Acid

All patients received TPN for 5 days postoperatively, according to a standard protocol: 3 g/kg BW glucose (5% Dextrose in Ringer's Lactate, Biosel, Istanbul), 1.2 g/kg BW amino acids (Aminosteril 10%, Fresenius-Kabi) and 0.8 g/kg BW omega-6 fatty acids (Lipovenoes® 10%, Fresenius-Kabi) were provided to both groups through an indwelling central venous catheter. In the omega-3 group, the lipid content of TPN was replaced partially by omega-3 fatty acids (Omegaven®, Fresenius-Kabi) up to 0.2 g/kg BW per day.

All patients received TPN for 5 days postoperatively, according to a standard protocol: 3 g/kg BW glucose (5% Dextrose in Ringer's Lactate, Biosel, Istanbul), 1.2 g/kg BW amino acids (Aminosteril 10%, Fresenius-Kabi) and 0.8 g/kg BW omega-6 fatty acids (Lipovenoes® 10%, Fresenius-Kabi) were provided to both groups through an indwelling central venous catheter.

Lipovenoes® 10% and Omegaven®,

Pre- and intra-operative nutritional support in patient undergoing major surgery results in decreased morbidity and mortality. Studies investigating the role of omega-3 fatty acids in these patients are increasing. Some are focused on perfusion at the cellular level. This study was undertaken to address the effect of postoperative administration of omega-3 fatty acids on cellular hypoperfusion associated with major gastric surgery.

Impact of Omega-3 Fatty Acids on Lactate

Do Omega-3 Fatty Acids Have Any Impact On Serum Lactate Levels After Major Gastric Cancer Surgery?

Ege University

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

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

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Epirubicin

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

8 weekly cycles of chemotherapy with epirubicin (50 mg/m2)associated with cisplatin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.

8 weekly cycles of chemotherapy with cisplatin (30 mg/m2) associated with epirubicin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.

8 weekly cycles of chemotherapy with paclitaxel (90 mg/m2) associated with epirubicin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.

surgery will be scheduled within 4-6 weeks after the end of the last cycle of chemotherapy.

gastric surgery

If surgery remains the main treatment for gastric cancer without distant metastases; perioperative-chemotherapy increased the likelihood of progression free survival. Perioperative chemotherapy appears to have many advantages : to reduce the tumor volume, to improve the R0 resection rate, and to act on micro-metastases. Therefore, peri-operative chemotherapy combining cisplatin, epirubicin and 5-Fluorouracile is a validated strategy to treat gastric cancer. However, several pitfalls remained. Particularly, only 42% of patients could received post-chemotherapy, due to post-operative complications and toxicities. To overcome this limitation, the investigators will conduct a phase II clinical trial assessing the clinical interest of a dose-dense preoperative chemotherapy combining cisplatin (P), epirubicin (E) and paclitaxel (T). The increasing evidence of taxane's role in gastric cancer treatment, as well as the biological synergisms reported in paclitaxel/cisplatin and paclitaxel/epirubicin combinations, sustain the development of dose density based on PET combination in gastric carcinoma. The aim of the IPEC-GC study is to evaluate the effectiveness of this PET preoperative regimen

The IPEC-GC study is a proof-of-concept study evaluating the efficacy and feasibility of PET regimen in 61 patients with lower oesophagus, oesophagus junction or gastric carcinoma.

Preoperative chemotherapy include eight weekly preoperative cycles of cisplatin (30mg/m2), epirubicin (50 mg/m2) and paclitaxel (90 mg/m2)with a break of one week without chemotherapy between cycle 4 and 5. Surgery is performed within 4-6 weeks after the end of the last cycle of chemotherapy. Primary endpoint of this trial is the curative resection rate (=R0). R0 must be higher than the 79% achieved in previous published studies. Response rate, histologic response rate (Becker score), progression-free survival, overall survival, impact of complete response in survival and dose-density are secondary endpoints. For an ancillary study, tumors (biopsies and operative specimens) and sera will be collected to identify biomarkers correlated with treatment efficacy.

This study is carried out by the Besançon University Hospital and were approved by the independent Est-II ethics committee and by the French National Authority for Health: AFSSAPS.

Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer

Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study.

Response rate will be evaluated using RECIST v1.1 criteria (Response Evaluation Criteria in Solid Tumors ; Eisenhauer et al, 2009) by a CT-scan done between 2 and 4 weeks after the end of the last cycle to verify the absence of local or distant progression before surgery

Histologic response rate will be determined by the pathologist laboratory on operative specimens using Becker's score (Becker et al, 2003) to measure effects of neoadjuvant chemotherapy on gastric cancer.

Toxicities will be evaluated using Common Terminology Criteria for Adverse Events version 4.

Centre Hospitalier Universitaire de Besancon

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

Heart and Blood Diseases

Thromboembolism

Venous Thromboembolism

Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Patients receiving gastric cancer surgery will be prospectively observed for the development of venous thromboembolism

Gastric surgery

Venous thromboembolism (VTE) has considerably harmful effects on morbidity and mortality of cancer patients. Several guidelines recommendations have been made about the use of anticoagulation for the prevention and treatment of VTE in Western patients with cancer. In Western VTE guidelines, all solid cancer patients receiving abdominal major surgery are strongly recommended to receive pharmacologic prophylactic anticoagulation such as low molecular weight heparin (LMWH) in the perioperative periods. These guideline recommendations are based on high incidence of postoperative VTE development in Western cancer patients. However, there have been many cumulative data about the effect of different ethnicity on the VTE development and more and more investigators and clinicians admit that Asian ethnicity has lower incidence of VTE than Western ethnicity. Therefore, it may not be advisable to apply Western guidelines as it is to the clinical situation of Asian cancer patients.

Although gastric cancer is the common cancer in Asia, there is no prospective data on the incidence of VTE development during the postoperative period of gastric cancer surgery. In other words, Asian doctors including Korean clinicians don't know the exact incidence of surgery-related VTE. From their clinical experiences, most Korean surgeons think that the incidence of postoperative VTE development is rare. They also have much concern about the complications such as bleeding that might be caused by routine use of pharmacologic thromboprophylaxis during the perioperative periods. Therefore, in most clinical situation, Korean surgeons do not perform perioperative pharmacologic thromboprophylaxis using LMHW. Considering these clinical situations in Korea, the uncritical acceptance of Western guidelines is inappropriate. The necessity of pharmacologic thrombo-prophylaxis can be answered only from the results of the prospective study on the incidence of postoperative VTE development after gastric cancer surgery. Moreover, current surgical trend in cancer patients is minimally invasive approach such as laparoscopic surgery. However, the necessity of pharmacologic thromboprophylaxis in patients receiving laparoscopic cancer surgery has not been evaluated even in Western countries. Western guidelines also cannot exactly answer whether pharmacologic thromboprophylaxis is really necessary in cancer patients receiving laparoscopic cancer surgery. On above backgrounds, this study was designed.

Incidence of Venous Thromboembolism Following Surgery in Patients With Gastric Cancer

Incidence of Venous Thromboembolism Following Surgery in Patients With Gastric Cancer; a Prospective Study

To evaluate the incidence of symptomatic or asymptomatic VTE detected by Doppler venous ultrasound during postoperative periods in patients with gastric cancer receiving surgery

To identify risk factors for the development of VTE in this population

Seoul National University Bundang Hospital

M.D. & Ph.D.

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Infections

Syndrome

Lung Diseases

Liver Diseases

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Pulmonary Atelectasis

Pneumonia

Edema

Pleural Effusion

Pneumothorax

Pancreatic Diseases

Pulmonary Edema

Airway Obstruction

Respiratory Distress Syndrome, Infant

Acute Respiratory Distress Syndrome

Acute Graft Versus Host Disease

Hematinics

Liver Extracts

Marc Bodenstein

The purpose of this study is to determine whether Electrical Impedance Tomography can be used as sensitive and specific predictor in the detection of postoperative pulmonary complications (e.g. pneumonia, bronchitis, acute respiratory distress syndrome, pleural effusion, pneumothorax, pulmonary edema, atelectasis, pulmonary embolism, hypoxemia, hypercapnia, spasms and obstructions of the airway) in patients undergoing epigastric surgery.

* Study cycle:

  1. Check of criteria of inclusion/exclusion
  2. Informed consent
  3. Recording preoperative data via paper case report form
  4. Preoperative EIT measurement
  5. Postoperative EIT measurement
  6. Recording postoperative data via paper case report form

     Patients therapy and any diagnostic investigation during hospital stay (apart from EIT measurement) are performed appropriate to patients individual clinical needs and are independent from participation in this clinical trial. As PPC may result from surgical complications (e.g. intra- /postoperative bleeding, anastomotic leak, infection of the wound, injury of neighboring organs) they are monitored.
* Statistical analysis:

Sample size:

After consultation of Johannes-Gutenberg-University Institute of Medical Biometry and Epidemiology the following procedure was developed: Pre-analysis with 20 patients, then determination of definitive sample size (advised 80 patients).

Population:

Any registered patient is included in population even if no study-treatment was performed. To fulfill Pre-Protocol-Population-criteria EIT-measurement has to be performed before and after elective epigastric surgery and information about PPC must be revealable from patients medical file/records.

* Analysis of efficacy:

  1. Primary objective:

     (A) Incidence of any PPC (postoperative pulmonary complication) until postoperative day 7; Acquisition of PPC might require diagnostic investigation during hospital stay; investigations are only performed appropriate to patients individual clinical needs. As PPC are defined:
     * I: desaturation, increased oxygen demand (data from electronic health record)
     * II: dys-/atelectasis, pleural effusion, pneumothorax, pulmonary vein congestion (data from thoracic x-ray)
     * III: detected respiratory infection/pneumonia, pulmonary edema, Aspiration, non-invasive/CPAP-Ventilation, necessity of pleural drain/of bronchoscopy (data from electronic health record, x-ray)
     * IV: Reintubation (data from electronic health record), ARDS (according to Berlin Definition)

     (B) regional Distribution of Ventilation (Analysis of EIT raw data pre- and postoperative in 4 regions of interest: ventral, mid-ventral, mid-dorsal, dorsal; correlation between PPC and difference in regional Distribution of Ventilation at defined moment)
  2. Secondary objective: post-hoc Analysis (see down Secondary Outcome Measure)

     Average, Median, Quartile, Standard Deviation are detected and shown in Box-plots (type of graphic). Explorative comparison of parameters is effected by t-Test, Mann-Whitney-U-Test, Fisher-Test dependent on normal distribution.
* Quality assurance and data management Design, execution and analyzation of the study is ICH-GCP-conform (Good-Clinical-Practice-Guideline of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). All responsible persons are obliged to good clinical practice. All changes in study protocol are to be authorized by responsible Ethics Committee. The P.I. is responsible for source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms).

Prior to written informed consent all patients are to be informed about character and consequences of the study. With their signature patients permit collection and use of source data. Every patient receives an Identification code for pseudonymization of data. Analyzation and publication of data is effected anonymously only. Data collection is mainly provided in an electronic data base, besides in a paper-based Case Report Form. All electronic and paper-based data and archived in our Clinical Research Center and are accessible for authorized persons (Monitor, Auditor). The study protocol does not provide audits.

Amendment after Pre-analysis:

We conducted a preliminary study of 23 patients for sample size calculation, aligned with the goal of predicting probability of relevant PPC. Power calculation was based on the assumption that 50 % of patients would develop relevant PPC. We performed a power analysis using the Wilcoxon test. The assumption was that AUC of EIT-parameters for distinguishing PPC-affected patients from non-affected patients would be at least 0.65. In order to demonstrate that AUC is indeed above 0.5, a Wilcoxon test can be applied. AUC=0.65 translates into P(X\<Y)=0.65. To demonstrate this at the 5%-significance level with a power of 80%, 116 patients are needed. Considering that approximately 10% of patients may not be evaluable, a total sample size of 130 patients was determined. Interim analysis revealed, that incidence of relevant PPC in the study cohort was lower than assumed in sample size calculation. Therefore a higher sample size was necessary than expected. Furthermore, recruiting was slow. We therefore switched from a confirmatory to a descriptive approach.

Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography

Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography in Intensive Care Patients Undergoing Epigastric Surgery

Comparison of the changed regional ventilation partition to the occurence of postoperative pulmonary complications =\> calculation of sensitivity and specifity of the primary outcome measure to predict PPC. Statistical analysis: receiver operating characteristic (ROC curve).

Sensitivity and specifiy for appearance of PPC (Postoperative Pulmonary Complications) within Postoperative Day 1-7.

Statistical analysis: Sensitivity, Specificity, ROC-curve

Correlation of pre-existing pathologic pulmonary conditions with specific postoperative changes in regional distribution of lung ventilation and perfusion assessed by EIT Statistical analysis: Sensitivity, Specificity, ROC-curve

Appearance of all different forms of PPC within Postoperative Day 1-7 and relation to postoperative EIT-measure (ROI analysis in 8 pulmonary ROIs).

Statistical analysis: Sensitivity, Specificity, ROC-curve

Sensitivity and specifity of postoperative EIT-measure for mortality. Statistical analysis: Sensitivity, Specificity, ROC-curve

Sensitivity and specifity of postoperative EIT-measure for time of intensive care therapy.

Statistical analysis: Sensitivity, Specificity, ROC-curve

Sensitivity and specifity of postoperative EIT-measure for Ventilator-obligatory-free days.

Statistical analysis: Sensitivity, Specificity, ROC-curve

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Omega-3 Fatty Acids on Lactate	NCT00929461	Gastric Surgery	Lipovenoes® 10%...	25 Years - 65 Years	Ege University
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
Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer	NCT01830270	Stomach Neoplas... Oesophageal Jun... Lower Oesophagu...	Epirubicin Cisplatin Paclitaxel gastric surgery	18 Years - 70 Years	Centre Hospitalier Universitaire de Besancon
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
Incidence of Venous Thromboembolism Following Surgery in Patients With Gastric Cancer	NCT01345773	Gastric Cancer Venous Thromboe... Postoperative P...	Gastric surgery	20 Years -	Seoul National University Bundang Hospital
Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer	NCT01830270	Stomach Neoplas... Oesophageal Jun... Lower Oesophagu...	Epirubicin Cisplatin Paclitaxel gastric surgery	18 Years - 70 Years	Centre Hospitalier Universitaire de Besancon
Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer	NCT01830270	Stomach Neoplas... Oesophageal Jun... Lower Oesophagu...	Epirubicin Cisplatin Paclitaxel gastric surgery	18 Years - 70 Years	Centre Hospitalier Universitaire de Besancon
Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography	NCT02337673	Pulmonary Disea... Postoperative R... Malignant Neopl... Liver Diseases Pancreatic Dise...		18 Years -	Johannes Gutenberg University Mainz

Spots Global Cancer Trial Database for gastric surgery