Extensive Intraoperative Peritoneal Lavage After Curative Gastrectomy for Locally Advanced Gastric Cancer (SEIPLUS) (SEIPLUS)
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Extensive Intraoperative Peritoneal Lavage, EIPL, Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
- ECOG score standard (ECOG)performance status of 0 or 1 and expected to survive more than 6 months.
- Without any other malignancies.
- Written informed consent from the patient.
- Histologically proven primary gastric adenocarcinoma.
- Patients planned for open gastrectomy.
- Patients who have T3 (subserosal) or T4 (serosal) disease based on Ultrasound gastroscopy and intra-operative inspection with any N staging and M0 gastric cancer.
- No preoperative neoadjuvant chemotherapy.
- Length of esophageal invasion≤3cm and no need of thoracotomy for resection.
Intraoperative inclusion criteria:
- Clinically T3, T4a or T4b.
- Clinically H0 and M0. No peritoneal dissemination or Distant metastases.
- Possible for R0 surgery.
Exclusion Criteria:
- Female in pregnancy or lactation.
- Supraclavicular lymph nodes metastases,pelvis or ovarian implantation,peritoneal dissemination,liver,lung and bone metastases.
- Massive ascites or cachexia.
- Patients participating in any other clinical trails currently,or participated in other trails within 1 months.
- Without a history of stomach or esophageal cancers, including stromal tumor,sarcoma,lymphoma and carcinoid.
- Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
- Patients with poor compliance or considered to be poor compliance.
Sites / Locations
- Anqing Municipal Hospital
- Anhui Provincial Hospital
- The First Affiliated Hospital of Anhui Medical University
- First Affiliated Hospital of Wannan Medical College
- Cancer Center of Sun Yat-sen University
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- The First Affiliated Hospital of Guangdong Pharmaceutical University
- Yuebei People's Hospital
- Jiangsu Cancer Institute & Hospital
- Jiangxi Provincial Cancer Hospital
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Lishui Hospital of Zhejiang University
- Tianjin Medical University Cancer Institute and Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Extensive Intraoperative Peritoneal Lavage
Standard Treatment
Gastrectomy with D2 lymphadenectomy is performed. The peritoneal cavity of subject will be washed with 10 liters of warmed normal saline (1 liter per cycle for 10 cycles), followed by complete aspiration of the fluid . The abdomen will be closed as per standard.
Gastrectomy with D2 lymphadenectomy is performed. The peritoneal lavage will be done < 3 cycles with 3 liters or less of warmed normal saline. The abdomen will be closed as per standard.