NCT05537129 Laparoscopic vs Open Total Gastrectomy for Gastric Cancer
| NCT ID | NCT05537129 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2024-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2022-10-01 with a primary completion date of 2024-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.
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
Contact & Investigator
Dazhi Xu, PHD,MD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT05537129 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05537129 currently recruiting?
Yes, NCT05537129 is actively recruiting participants. Contact the research team at xudzh@shca.org.cn for enrollment information.
Where is the NCT05537129 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05537129 clinical trial?
NCT05537129 is sponsored by Fudan University. The principal investigator is Dazhi Xu, PHD,MD at Fudan University. The trial plans to enroll 600 participants.
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