Ignite Creation Date:
2024-05-06 @ 3:34 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02313688
Status:
UNKNOWN
Last Update Posted:
2017-12-11
First Post:
2014-12-07
Brief Title:
Length of the Proximal Resection Margin for Siewert-IISiewert-III Tumors
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
The Relationship Between the Length of the Proximal Resection Margin and Long-term Survival for Adenocarcinomas of the Esophagogastric Junction Siewert-IISiewert-III- Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2017-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The incidence of adenocarcinomas of the esophagogastric junction AEJ has increased rapidly during the past decades By the Siewert classification the AEJ is the tumor center located 5 cm above the anatomic cardia and 5 cm below it which is divided into three individual subtypes Complete tumor resection is the primary therapy strategies for tumors of the AEJ The Japan Clinical Oncology Group 9502 JCOG 9502 found that transabdominal or transhiatal approach gastrectomy has better survival outcomes compared with left thoracoabdominal approach surgery for Siewert IIIII tumors Transabdominal approach gastrectomy is recommended as the standard treatment strategy for Siewert IIIII tumors by the guidelines of the Japanese Gastric Cancer Association JGCA However the length of the proximal resection margin for Siewert-IIIII tumors by transabdominaltranshiatal gastrectomy is still controversies Previous study found that longer than 2cm proximal resection margin had better survival outcome than less than 2cm proximal resection margin for Siewert-IIIII tumors On the other sides due to more advanced tumor stage of patients in China when compared with Japan and Korea It is necessary to conduct a randomized control study to analyze the length of resection margin in advanced adenocarcinomas of esophagogastric junction
Therefore this study was aimed to include those Siewert IIIII tumor patients in Gastrointestinal Surgery Department West China Hospital Sichuan University to analyze the relationship between the length of proximal resection margin and survival outcomes
Therefore this study was aimed to include those Siewert IIIII tumor patients in Gastrointestinal Surgery Department West China Hospital Sichuan University to analyze the relationship between the length of proximal resection margin and survival outcomes
Detailed Description:
Standard Operating Procedure SOP
1 Preoperative evaluation Patients satisfied with inclusionexclusion criteria will be informed to join in the clinical study and signature the inform consent
2 Randomization Intraoperative evaluation found that transabdominal or transhiatal R0 D2 lymphadenectomy total gastrectomy can be performed the case will entrance into the Randomization period Random numbers are computer-generated with the third party applications
3 Surgical procedures The surgical treatments is adopted the total gastrectomy according to the Japanese Gastric Cancer treatments guidelines 2010 Version 3 Patients in the Group A with 3cm length proximal resection margin and patients in the Group B with 5cm length proximal resection margin Intraoperative frozen section will routinely performed to secure the tumor free resection margin If the positive resection margin is found by the intraoperative frozen section supplementary resection was depend on the characteristics of each patients Whether these patients with supplementary resection the length of supplementary resection and the times of the supplementary resection are all needed to record The two study will take the similar surgical procedures except for the length of the resection margin
4 Postoperative recovery Postoperative recovery period need to collect those relevant parameters of all the patients All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative intraoperative and postoperative clinicopathologic characteristics
5 Follow-up The follow-up of this study divide into two parts the postoperative complications and survival outcomes The postoperative complications is graded by the Clavien-Dindo classification The survival outcomes included recurrence type relapse free survival months and the overall survival months
1 Preoperative evaluation Patients satisfied with inclusionexclusion criteria will be informed to join in the clinical study and signature the inform consent
2 Randomization Intraoperative evaluation found that transabdominal or transhiatal R0 D2 lymphadenectomy total gastrectomy can be performed the case will entrance into the Randomization period Random numbers are computer-generated with the third party applications
3 Surgical procedures The surgical treatments is adopted the total gastrectomy according to the Japanese Gastric Cancer treatments guidelines 2010 Version 3 Patients in the Group A with 3cm length proximal resection margin and patients in the Group B with 5cm length proximal resection margin Intraoperative frozen section will routinely performed to secure the tumor free resection margin If the positive resection margin is found by the intraoperative frozen section supplementary resection was depend on the characteristics of each patients Whether these patients with supplementary resection the length of supplementary resection and the times of the supplementary resection are all needed to record The two study will take the similar surgical procedures except for the length of the resection margin
4 Postoperative recovery Postoperative recovery period need to collect those relevant parameters of all the patients All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative intraoperative and postoperative clinicopathologic characteristics
5 Follow-up The follow-up of this study divide into two parts the postoperative complications and survival outcomes The postoperative complications is graded by the Clavien-Dindo classification The survival outcomes included recurrence type relapse free survival months and the overall survival months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None