Extensive Intraoperative Peritoneal Lavage After Curative Gastrectomy for Locally Advanced Gastric Cancer (SEIPLUS) (SEIPLUS)
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| ClinicalTrials.gov Identifier: NCT02745509 |
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Recruitment Status :
Completed
First Posted : April 20, 2016
Last Update Posted : February 21, 2019
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The investigators study aims to explore the potential function of extensive intraoperative peritoneal lavage in improving the overall survival and progression-free survival for locally advanced gastric cancer after curative resection.
Hypothesis: Overall survival and progression-free survival of locally advanced gastric cancer are improved by extensive intraoperative peritoneal lavage.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Cancer | Other: Extensive Intraoperative Peritoneal Lavage | Not Applicable |
Gastric cancer has been one of the most frequently common cancers and remains the third leading cause of death among malignant tumors all over the world. Surgery has always been considered as the most effective treatment. While significant surgical technique and perioperative management have dramatically improved the survival of patients with advanced gastric cancer, patients with T4 stage or serosal-positive gastric cancer often suffer from recurrence as peritoneal dissemination, and the prognosis of those patients is extremely poor. Despite curatively resected, Peritoneal metastasis is completed by the implantation of peritoneal free cancer cells exfoliated from serosa-invasive tumors. Therefore, things need to be done to eliminate the free exfoliated cancer cells on the peritoneal lining in order to reduce the risk of peritoneal recurrence.
A multi-institutional prospective, randomized trial has been launched by Kuramoto recently. The trail was intended to demonstrate the superiority in overall survival of addition of Extensive Intraoperative peritoneal Lavage (EIPL) to standard treatment in patients with≥T3 carcinoma of stomach. Based on the'limiting dilution theory', after total or distal gastrectomy with D2 lymphadenectomy, the peritoneal cavity is extensively rinsed 10 times with 1 L physiological saline at a time, followed by complete aspiration of the fluid. In total, 10 L saline is to be used. In this study, the EIPL-IPC group had a significantly lower incidence of peritoneal recurrence. Furthermore, the 5-year overall survival rate of the patients in the EIPL-IPC group (43.8%) was significantly better than that of the intraperitoneal chemotherapy (IPC) group (4.6%) and the surgery-alone group (0%). All in all, EIPL is easy to carry out, safe and inexpensive. Therefore, gastrectomy with EIPL will be a new standard treatment of gastric cancer.
To ensure the quality of the study, two interim analyses will be planned at the half and the completion of the study respectively. The Data and Safety Monitoring Committee will independently review the interim analysis and stop the study ahead of schedule if necessary. Furthermore, to improve the study progress and quality, the in-house interim monitoring will be performed.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 508 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Investigation the Value of Extensive Intraoperative Peritoneal Lavage After Curative Gastrectomy for Locally Advanced Gastric Cancer |
| Study Start Date : | March 2016 |
| Actual Primary Completion Date : | November 2017 |
| Actual Study Completion Date : | November 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Extensive Intraoperative Peritoneal Lavage
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.
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Other: Extensive Intraoperative Peritoneal Lavage
Extensive Intraoperative Peritoneal Lavage
Other Name: EIPL |
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No Intervention: Standard Treatment
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.
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- Overall survival [ Time Frame: 3-year ]The survival rate between the surgery to the 3rd year due to all-cause death or last follow-up.
- Disease-free survival [ Time Frame: 3-year ]The progression-free or all-cause death rate between the surgery and the 3rd year.
- Peritoneal recurrence [ Time Frame: 3-year ]The Peritoneal recurrence rate between the surgery and the 3rd year
- Postoperative complications [ Time Frame: an average of 10 days ]complications such bleeding, infection, obstruction and leakage
- Post-operative quality of life [ Time Frame: an average of 10 days ]The postoperative quality of life will be assessed by factors such as Swallowing，Pain and discomfort，Dietary restrictions, Upper gastrointestinal symptoms, mental status and others.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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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.
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): NCT02745509
| China, Anhui | |
| Anqing Municipal Hospital | |
| Anqing, Anhui, China | |
| Anhui Provincial Hospital | |
| Hefei, Anhui, China | |
| The First Affiliated Hospital of Anhui Medical University | |
| Hefei, Anhui, China | |
| First Affiliated Hospital of Wannan Medical College | |
| Wuhu, Anhui, China | |
| China, Guangdong | |
| Cancer Center of Sun Yat-sen University | |
| Guangzhou, Guangdong, China | |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | |
| Guangzhou, Guangdong, China | |
| The First Affiliated Hospital of Guangdong Pharmaceutical University | |
| Guangzhou, Guangdong, China | |
| Yuebei People's Hospital | |
| Guangzhou, Guangdong, China | |
| China, Jiangsu | |
| Jiangsu Cancer Institute & Hospital | |
| Nanjing, Jiangsu, China | |
| China, Jiangxi | |
| Jiangxi Provincial Cancer Hospital | |
| Nanchang, Jiangxi, China | |
| China, Zhejiang | |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | |
| Hangzhou, Zhejiang, China | |
| Lishui Hospital of Zhejiang University | |
| Lishui, Zhejiang, China | |
| China | |
| Tianjin Medical University Cancer Institute and Hospital | |
| Tianjin, China | |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dazhi Xu, Study Chair, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT02745509 |
| Other Study ID Numbers: |
SEIPLUS |
| First Posted: | April 20, 2016 Key Record Dates |
| Last Update Posted: | February 21, 2019 |
| Last Verified: | February 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Extensive Intraoperative Peritoneal Lavage EIPL Gastric Cancer |
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Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |