Neoplasms

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Stomach Neoplasms

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Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

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Neoplasms by Histologic Type

Abdominal Neoplasms

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Stomach Cancer

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1. Staging laparoscopy + peritoneal lavage.
2. 4 cycles of neoadjuvant chemotherapy: FLOT = Docetaxel 50 mg/m², Oxaliplatin 85 mg/m², Leucovorin 200 mg/m², 5-FU 2600 mg/m² every 2 weeks.
3. Radical gastrectomy with D2 - lymph node dissection.
4. Intraoperative Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin 7,5 mg/m², doxorubicin 1,5 mg/m².
5. Adjuvant chemotherapy according to indications.

1. Staging laparoscopy + peritoneal lavage.
2. 4 cycles of neoadjuvant chemotherapy: FLOT = Docetaxel 50 mg/m², Oxaliplatin 85 mg/m², Leucovorin 200 mg/m², 5-FU 2600 mg/m² every 2 weeks.
3. Radical gastrectomy with D2 - lymph node dissection.
4. Adjuvant chemotherapy according to indications.

All patients undergo staging laparoscopy and peritoneal lavage.

Staging laparoscopy

5-Fluorouracil

Radical gastrectomy with D2 - lymph node dissection.

Radical surgery

Intraoperative Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin 7,5 mg/m², doxorubicin 1,5 mg/m².

PIPAC

Adjuvant chemotherapy according to indications.

Adjuvant chemotherapy

Alexander Zakharenko, PhD

Michael Belyaev, PhD

Ilya Vervekin

Stomach cancer is recognized as the third leading cause of death of cancer patients worldwide. Despite the radical treatment carried out, the progression of gastric cancer occurs in 30-40% of patients. The most common type of tumor progression of this localization is peritoneal carcinomatosis. When peritoneal carcinomatosis occurs, the median survival of patients does not exceed 3 months, the overall survival is no more than 6 months. Unfortunately, when peritoneal carcinomatosis occurs, palliative chemotherapy remains the only treatment option. The modern strategy for the prevention and treatment of peritoneal carcinomatosis is based on the concept of regional chemotherapy. The main methods of regional chemotherapy are hyperthermic intraperitoneal chemotherapy (HIPEC) and Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC). PIPAC is a new technology for delivering chemotherapy drugs to tumor nodes on the surface of the peritoneum and allows the cytostatic to be evenly distributed over the abdominal cavity, increasing the depth of its penetration into tumor nodes due to the properties of aerosol and gradients of intra-abdominal and interstitial pressure. The method has a number of advantages over the HIPEC method: a large penetration depth of drugs, low trauma, the possibility of repeated use. We offer PIPAC for patients with locally advanced gastric cancer and a high risk of developing peritoneal carcinomatosis in an adjuvant mode in addition to standard treatment to prevent the development of carcinomatosis.

The study is interventional: patients over 18 years of age with an established diagnosis of stomach cancer (c)T3-4N0-3M0 CYT- will be randomized into 2 groups using the envelope method. The control group will receive only neoadjuvant chemotherapy + gastrectomy/ distal subtotal resection with D2 lymph node dissection, the active comparison group - neoadjuvant chemotherapy + gastrectomy with D2 lymph node dissection + PIPAC (Cisplatin (7.5 mg / m²) + Doxirubicin 1.5 mg / m2)). Will be assessed: overall survival, median survival, disease-free survival, quality of life of patients.

Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt-

Single-center Randomized Study Evaluating of Oncological Benifits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With Locally Advanced Gastric Cancer in Patients With Cyt-.

Overall survival (OS) where OS is defined as the time from randomization to death from any cause.

Overall survival rates at 3 \& 5 years defined as the percentage patients known to be alive after 3 and 5 years referring to the total number of patients randomized into the respective treatment arm

PFS/DFS is defined as the time from randomization to disease progression or relapse after surgery or death from any cause.

Peritoneal relapse rate defined as the percentage of patients with peritoneal relapse referring to the total number of patients randomized into the respective treatment arm

PFS/DFS rates at 2, 3 \& 5 years defined as the percentage of patients without disease progression or relapse after surgery or death from any cause after 2, 3 and 5 years referring to the total number of patients randomized into the respective treatment arm

Rate of surgical serious adverse events, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0) grade ≥ 3 adverse events and grade ≥ 3 laboratory toxicities.

The QoL analyses will include QoL mean values, QoL response and time to symptom deterioration (TTSD) defined as the time interval between randomization and the first decrease by ≥ 10-points. All randomly assigned patients with a baseline and at least one post-baseline assessment will be included in TTSD analyses. Patients without observed deterioration will be censored at the time of their last QoL assessment. Questionnaires given to the patients (validated quality of life questionnaires EORTC QLQ C30).

EORTC QLQ C30 contains 30 questions:

28 questions regarding body fitness, daily routines, restrictions at work and hobby, appetite, fatigue, cough, breathlessness, pain, tiredness, and body conditions from (1) to (4); 1 (not a bit), 2 (little), 3 (moderate), 4 (much).

2 questions regarding state of health and Quality of life with a horizontal rating from 1 to 7; 1 (very bad), 7 (excellent).

The patient´s assessment of their current level of pain on a 100-mm horizontal VAS. The left-hand extreme of the line should be described as "no pain" and the right-hand as "unbearable pain".

Rate of post-operative morbidity/mortality will be assessed at day 30 after surgery acc. to Clavien-Dindo classification.

St. Petersburg State Pavlov Medical University

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Biliary Tract Cancer

Liver Extracts

Resectable pancreatobiliary cancer confirmed by radiologic studies (CT scan, MRI, PET-CT) and no evidence of distant metastasis.

Staging laparoscopy will perform through 2 ports and a 30˚ laparoscope is inserted into the peritoneal cavity. Examining the whole abdominal wall, including the parietal and visceral peritonea, we will observe the liver surface from the dome area to the inferior surface and hepatoduodenal ligament in order to find metastatic nodules. Laparoscopic ultrasound (US) will be used to overcome in inspecting the posterior part of the liver. After complete laparoscopic examination, peritoneal lavage will be performed through the laparoscopic port.

Staging Laparoscopy

Laparoscopic ultrasound

Sang Jae Park, MD

The purpose of this study is to evaluate the role of routine Staging Laparoscopy in patients with potentially resectable pancreatobiliary cancer.

To evaluate the role of routine staging laparoscopy in patients with potentially resectable pancreatobiliary cancer. All analyses are performed using SAS version 9.1.3 for Windows (SAS institute, Cary, NC). Clinical and pathological variables will be analyzed using the χ2 test (or Fisher's exact test) and the Student's t test, depending on the normality of the distribution. P-values of \< 0.05 are considering statistically significant.

Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

A Prospective Study Investigating the Role of Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer

Probability of diagnosis of metastasis (frequency)

National Cancer Center, Korea

Center for Liver Cancer

Symptoms and General Pathology

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasm Metastasis

COVID-19

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Depressants

Anesthetics

26 patients with gastric cancer wo were referred to our center between February 25th to December 25th of 2020.

54 patients with gastric cancer wo were referred to our center between February 25th to December 25th of 2019.

All patients of both groups underwent staging laparoscopy by the same two attending onco-surgeon, using the same technique and the same laparoscopic device. Under general anesthesia and in supine position SL was performed. A 10 mm optic laparoscopic port was inserted via the midline incision below the umbilicus using Hasson technique. All four quadrants of the abdomen as well as pelvis were inspected during laparoscopy and biopsy was taken from any suspicious lesion through insertion of 5mm port. All specimens underwent cytological evaluation by two independent pathologists. The presence of any malignant cells, regardless of the number, confirmed the positive cytology. In the event of discordant reports between two pathologists, specimens were sent for the third review by a pathologist who was blinded to the previous results. Laparoscopic evaluation was considered positive as if adjacent organ involvement, omental involvement or peritoneal seeding were seen.

staging laparoscopy

This was a retrospective case-control study designed and conducted under the approval of the ethic committee of Tehran University of Medical Sciences. All patients with gastric cancer referring to Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran, during February 25th and December 25th 2020, were enrolled to the study.

This was a retrospective case-control study designed and conducted under the approval of the ethic committee of Tehran University of Medical Sciences. All patients with gastric cancer referring to Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran, during February 25th and December 25th 2020, were enrolled to the study. February 25th was the day Ministry of Health and Medical Education announced COVID-19 as a national disaster and set restrictive rules of social distancing. The control group consisted of the gastric cancer patients whom referred to Cancer Institute during February 25th and December 25th of 2019. So the investigators compared two groups of gastric cancer patients one in the era of COVID-19 pandemic and other group from previous year when there was no COVID-19.

Cancer Institute as the pioneer of cancer management in Iran set institutional regulation for hospitalization of cancer patients during COVID-19 pandemic with the primary goal of delivering the best available treatment as timely as possible. In order to achieve this, each patient regardless of cancer type must had proceeded these steps before elective hospitalization and during preoperative, operation and postoperative days:

1. Prior to hospitalization, patients were referred to infectious disease clinic, where they were visited by attending infectious disease specialists who had fellowship in infectious disease of immunocompromised and transplanted patients. Every patient monitored for COVID-19 sign and symptoms and those with high susceptibility were examined utilizing spiral chest computed tomography scan (SCCT) and polymerase chain reaction (PCR) for SARS-CoV-2. If a patient had positive result of either SCCT or PCR, he/she was managed either in outpatient or inpatient setting for COVID-19 treatment based on national protocol and subsequent cancer management was postponed. If it was confirmed that patient is eligible for hospitalization and entering operation room, he/she was admitted to surgical oncology ward.
2. During pre-operative days, all patients were hospitalized in single or double bed room, family members were not allowed to accompany except for under legal aged patient and those who need special attention because of the low performance status. All patients were educated about COVID-19 transmission routs and preventive measures and asked to respect social distancing, wear facial mask and wash hands using alcohol- based antiseptic formulas given. Each patient underwent daily monitoring for sign and symptoms of COVID-19, heart rate, blood pressure, temperature and oxygen saturation by commercially available pulse oximetry devices. In case of developing signs and symptoms related to COVID-19 or unexplained temperature \> 38°C, oxygen saturation \< 93% or \> 5 unit drop in oxygen saturation from the baseline, infectious disease consultation was ordered.
3. During operation time, the minimum number of personnel needed to activate a safe operation environment whom were fully equipped with personal preventive clothing including surgical cap, gown, facial mask and shield were present at the theater. The operation theater was well ventilated.
4. During post-operative days, for both intensive care unit and ward patient, daily monitoring of signs and symptoms related to COVID-19 besides unexplained temperature \> 38°C, oxygen saturation \< 93% or \> 5 unit drop in oxygen saturation from the baseline, C-Reactive Protein Level \> 40 persistent for 3 days activated infectious disease consultation.

Patients of both case and control group were enrolled to the study as if they gave written consent of participation, had confirmed gastric cancer using esophago-gastro-duodenoscopy and pathologically proven biopsy and spiral thoraco-abdomino-pelvic computed tomography scan prior to surgery. All patients became candidates to undergo staging laparoscopy (SL) in order to investigate local and peritoneal invasion of the tumor based on National Comprehensive Cancer Network guideline for gastric cancer 2020. Patients with following criteria were excluded from the study; radiological evidence of metastatic disease, current or previous history of chemotherapy.

All patients of both groups underwent SL by the same two attending onco-surgeon, using the same technique and the same laparoscopic device. Under general anesthesia and in supine position SL was performed. A 10 mm optic laparoscopic port was inserted via the midline incision below the umbilicus using Hasson technique. All four quadrants of the abdomen as well as pelvis were inspected during laparoscopy and biopsy was taken from any suspicious lesion through insertion of 5mm port. All specimens underwent cytological evaluation by two independent pathologists. The presence of any malignant cells, regardless of the number, confirmed the positive cytology. In the event of discordant reports between two pathologists, specimens were sent for the third review by a pathologist who was blinded to the previous results. Laparoscopic evaluation was considered positive as if adjacent organ involvement, omental involvement or peritoneal seeding were seen.

Data were collected on the following variables: age, gender, tumor location, gastric lesion pathology and clinical stage based on the 8th edition of the American Joint Committee on Cancer tumor-node metastasis staging system for gastric cancer\[16\].

Categorical variables are shown as number and relative frequency. Also, continuous variables are shown as mean ± SD. Collected data for categorical variables were compared using the chi-squared test. An independent student t-test was used to compare means between the two groups. All analyses were performed by the two-sided method using Statistical Package of Social Science software (SPSS version 22; SPSS, Inc., Chicago, IL), and the p-value of \< 0.05 was set as statistically signiﬁcant.

in time of performing staging laparoscopy if any suspicious tissue for being malignant was encounter biopsied.

The Impact of COVID-19 Pandemic on Clinical Presentation and Staging of Gastric Cancer

data will be available up on reasonable request from Amirisina Sharifi.M.D.(a.s_sharifi@yahoo.com).

involvement of peritoneal cavity with metastatic gastric cancer.

involvement of peri-gastric lymph node with metastatic gastric cancer

Tehran University of Medical Sciences

Lymphatic Metastasis

Neoplastic Processes

Pharmaceutical Solutions

Patients will undergo upper GI endoscopy one day before SL will be dissolved in sterile water, resulting in a 0.125mg/ml concentration. 2 milliliters of the solution will be injected into the submucosa of 4 peritumoral sites - 0.5ml for each site. The following day patient will undergo SL

Intraoperative application of ICG-enhanced vision will be accomplished with dedicated optical devices. Alternate usage of white light and ICG fluorescence mode will allow precise location and cT stage determination of primary tumor, followed by identification of SN and its corresponding LN station, according to Japanese Gastric Cancer Association guidelines. Identified SN will be retrieved with a high-energy device, and the LN basin will be labeled with a magnetic clip.

The SN assessment will be conducted similarly to the method proposed by Märkl et al. All LNs will be stored in a -80 °C freezer, immediately after retrieval. Within 1 to 3 days, each LN will be individually measured and weighed. Small LNs (\<5 mm in short diameter) will be bisected, and half of the node will be processed for histological evaluation while the remaining half will be used for OSNA analysis. For intermediate-sized LNs (5-10 mm), a middle slice of about 2 mm thickness will be cut out for the histology, and the remaining parts of the node will be processed by OSNA. In large LNs (\>10 mm), at least two slices will be cut out for histology, and the remaining parts of the node will be analyzed by OSNA.

Sentinel Node Assessment

Pneumoperitoneum (10-12mmHg) will be obtained with Veress needle or 10mm trocar after minilaparotomy. Peritoneal cavity will be thoroughly assessed after insertion of two additional trocars. In cases of macroscopic dissemination, peritoneal cancer index (PCI) will be determined. After switching the optical camera into near-infrared / indocyanine green fluorescence mode, the primary tumor will be visualized, followed by assessment and possible dissection of sentinel lymph node with a high-energy device. The lymph node will be retrieved with a sterile bag, and the area of dissection will be marked with a clip. Trocars will be removed under visual assistance, and the pneumoperitoneum will be released through trocars in order to prevent port-site metastases.

Patients will undergo gastroscopy one day prior to staging laparoscopy. The ICG powder contains 0.125 mg/ml. Two milliliters of ICG (0.125mg/ml) solution is injected in the submucosa with into four peritumoral sites, 0.5 ml for each site.

Gastroscopy with indocyanine green (ICG) injection

Karol Rawicz-Pruszyński, MD,PhD

Katarzyna Sędłak, MD,PhD

Karol RawiczPruszyński, Professor

Staging LaParscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA) study aims to investigate the safety and feasibility of ICG-guided SN retrieval in GC patients undergoing multimodal treatment. The pretreatment clinical variables potentially associated with the procedure will also be analyzed.

To the best of our knowledge, the current study is the first to evaluate the role of ICG in SN biopsy in advanced GC patients undergoing multimodal treatment.

Comprehensive lymph node assessment seems to be critical for proper treatment strategy and survival prediction, particularly in advanced GC. Recent data on the sentinel node (SN) concept in early GC has shown favorable results regarding LN detection rate and clinical status determination. Staging laparoscopy (SL) with lavage cytology provides an additional value to the clinical staging of GC, particularly in detecting occult peritoneal disease. The role of Indocyanine green (ICG) guided SN mapping in GC confirmed its technical feasibility. ICG can be safely used to identify SN, determine the surgical resection line, improve the LN harvest, and reduce noncompliance in patients undergoing D2 lymphadenectomy.

The majority of the studies focused on the aspect of the increase in LN harvest. At the same time, no data exist regarding its potential role in GC nodal staging. To the best of our knowledge, the current study is the first to evaluate the role of ICG in SN biopsy in advanced GC patients undergoing multimodal treatment.

Patients with histopathologically confirmed, locally advanced adenocarcinoma of the stomach scheduled for staging laparoscopy by the multidisciplinary team will be classified for enrollment into this study.

Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer

Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer - POLA Study

The identification rate will allow confirmation of the safety and feasibility of ICG-guided SN biopsy during staging laparosocpy in advanced GC patients

SN retrieved during staging laparoscopy will undergo microscopic evaluation. The histopathological report will contain information on the character of the lymph node (benign/metastatic)

SN retrieved during gastrectomy will undergo microscopic evaluation. The histopathological report will contain information on the character of the lymph node (benign/metastatic) and its regression grade according to Becker classification

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt-	NCT04595929	Peritoneal Carc... Gastric Cancer	Staging laparos... 5-Fluorouracil Leucovorin Oxaliplatin Docetaxel Radical surgery PIPAC Adjuvant chemot...	18 Years - 65 Years	St. Petersburg State Pavlov Medical University
Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer	NCT02479984	Pancreatic Canc...	Staging Laparos... Laparoscopic ul...	15 Years - 80 Years	National Cancer Center, Korea
The Impact of COVID-19 Pandemic on Clinical Presentation and Staging of Gastric Cancer	NCT05130710	Gastric Cancer COVID-19 Pandem... Peritoneal Meta...	staging laparos...	-	Tehran University of Medical Sciences
Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt-	NCT04595929	Peritoneal Carc... Gastric Cancer	Staging laparos... 5-Fluorouracil Leucovorin Oxaliplatin Docetaxel Radical surgery PIPAC Adjuvant chemot...	18 Years - 65 Years	St. Petersburg State Pavlov Medical University
Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer	NCT05720598	Gastric Cancer Lymph Node Meta...	Sentinel Node A... Staging laparos... Gastroscopy wit...	18 Years - 90 Years	Medical University of Lublin
Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer	NCT05720598	Gastric Cancer Lymph Node Meta...	Sentinel Node A... Staging laparos... Gastroscopy wit...	18 Years - 90 Years	Medical University of Lublin
Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary Cancer	NCT02479984	Pancreatic Canc...	Staging Laparos... Laparoscopic ul...	15 Years - 80 Years	National Cancer Center, Korea

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