Laparoscopic vs Open Total Gastrectomy for Gastric Cancer
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ClinicalTrials.gov Identifier: NCT05537129 |
Recruitment Status :
Recruiting
First Posted : September 13, 2022
Last Update Posted : September 13, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer | Procedure: Total Gastrectomy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Compare the Survival, Morbidity and Mortality of Laparoscopic and Open Total Gastrectomy for Gastric Cancer |
Estimated Study Start Date : | October 1, 2022 |
Estimated Primary Completion Date : | October 1, 2024 |
Estimated Study Completion Date : | October 1, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Laparoscopic Total Gastrectomy |
Procedure: Total Gastrectomy
The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines. |
Active Comparator: Open Total Gastrectomy |
Procedure: Total Gastrectomy
The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines. |
- 3 year-DFS [ Time Frame: 3 year ]3 year-disease free survival
- 3 year-OS [ Time Frame: 3 year ]3 year-overall survival
- morbidity and mortality rates [ Time Frame: 30 days following surgeries ]morbidity and mortality within 30 days following surgeries
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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy)
- age between 20 and 80 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 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)
- 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
- written informed consent
- without preoperative chemotherapy and radiotherapy
Exclusion Criteria:
- clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System
- history of chemotherapy, radiotherapy, immunotherapy or target therapy
- perigastric lymphnode≥3cm
- received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
- multiple primary tumors
- suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
- patients need emergency operation with complication of gastric cancer
- adhesion due to the previous intraabdominal surgery
- need for combined organ resection due to aggression of gastric cancer of other disease,
- vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)
- currently participating or participated in other clinical trials in the last 6 months
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): NCT05537129
Contact: Dazhi Xu, PHD, MD | 021-64175590 | xudzh@shca.org.cn |
China, Shanghai | |
Fudan University Shanghai Cancer Center | Recruiting |
Shanghai, Shanghai, China | |
Contact: Dazhi Xu, PHD,MD 021-64175590 xudzh@shca.org.cn |
Principal Investigator: | Dazhi Xu, PHD,MD | Fudan University |
Responsible Party: | Dazhi Xu, PHD,MD, Fudan University |
ClinicalTrials.gov Identifier: | NCT05537129 |
Other Study ID Numbers: |
LOTGGC |
First Posted: | September 13, 2022 Key Record Dates |
Last Update Posted: | September 13, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gastric cancer, Laparoscopic Total Gastrectomy, Open Total Gastrectomy |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |