To hear about similar clinical trials, please enter your email below
Trial Title:
Laparoscopic vs Open Total Gastrectomy for Gastric Cancer
NCT ID:
NCT05537129
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Gastric cancer, Laparoscopic Total Gastrectomy, Open Total Gastrectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Total Gastrectomy
Description:
The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed
according to the Japanese gastric cancer treatment guidelines.
Arm group label:
Laparoscopic Total Gastrectomy
Arm group label:
Open Total Gastrectomy
Summary:
The aim of the present study is to demonstrated the the safety and feasibility of
laparoscopic total gastrectomy comparing with open total gastrectomy.
Detailed description:
Gastric cancer is most common cause of cancer-related deaths in the world. Laparoscopic
distal gastrectomy has been demonstrated to be safe and effective compared with open
distal gastrectomy. With an increase in incidences of proximal gastric cancer over the
last decades, total gastrectomy has been prefered by surgeons, and laparoscopic total
gastrectomy has become the alternative option. However, the safety and feasibility of
laparoscopic total gastrectomy have yet to be proved completely.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. histologically proven gastric adenocarcinoma in the upper or middle third of the
stomach (by preoperative gastrofiberscopy)
2. age between 20 and 80 years old
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal
Joint Committee on Cancer System (Clinical stage was determined based on the finding
of gastrofiberscopy and abdominal computed tomography)
5. scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery
by this procedures (Lymphadenectomy is performed on the basis of the criteria of the
Japanese
6. written informed consent
7. without preoperative chemotherapy and radiotherapy
Exclusion Criteria:
1. clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal
Joint Committee on Cancer System
2. history of chemotherapy, radiotherapy, immunotherapy or target therapy
3. perigastric lymphnode≥3cm
4. received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
5. multiple primary tumors
6. suffering from other serious diseases, including cardiovascular, respiratory,
kidney, or liver disease, complicated by poorly controlled hypertension, diabetes,
mental disorders or diseases.
7. patients need emergency operation with complication of gastric cancer
8. adhesion due to the previous intraabdominal surgery
9. need for combined organ resection due to aggression of gastric cancer of other
disease,
10. vulnerable people who cannot communicate or are pregnant (or planning to be
pregnant)
11. currently participating or participated in other clinical trials in the last 6
months
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Dazhi Xu, PHD，MD
Phone:
021-64175590
Email:
xudzh@shca.org.cn
Start date:
October 1, 2022
Completion date:
October 1, 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05537129
