Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients
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|ClinicalTrials.gov Identifier: NCT02246153|
Recruitment Status : Unknown
Verified January 2017 by Guoxin Li, Nanfang Hospital of Southern Medical University.
Recruitment status was: Recruiting
First Posted : September 22, 2014
Last Update Posted : January 10, 2017
- Laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer (EGC) has been supported by high-quality evidence, and the high-level evidence for advanced gastric cancer based on large prospective randomized controlled trial as CLASS-01、JCOG 0901, KLASS -02 is still awaited.Hopefully, it would have also gained the solid evidence of laparoscopy-assisted distal gastrectomy for the treatment of advanced gastric cancer (AGC).
- China has entered the aging society since 1999. Among the GC patients in China, the average age is 65 years old, which makes increasing attempts to explore laparoscopic techniques in the treatment of elderly patients.
- Nowadays, a considerable proportion of elderly patients suffer from multiple diseases, such as hypertension, diabetes, coronary heart disease. Thus the risk of intraoperative and postoperative complications can not be ignored. Unfortunately, there are rare studies specializing into the LAG for the GC patients of > 65 years old.
- Accordingly, the comparison of intraoperative and postoperative complications between laparoscopy-assisted and open distal gastrectomy for over 65 years old patients with gastric cancer based on a randomized controlled trial is warranted.
|Condition or disease||Intervention/treatment||Phase|
|Complications||Procedure: Laparoscopic gastrectomy Procedure: Open gastrectomy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Morbidity and Mortality of Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients: A Randomized Controlled Trial|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Laparoscopic gastrectomy
Laparoscopy-assisted distal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Procedure: Laparoscopic gastrectomy
Other Name: LDG
Active Comparator: Open gastrectomy
Open distal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Procedure: Open gastrectomy
Other Name: ODG
- Postoperative complication rate [ Time Frame: 30 days ]30 day morbidity and mortality
- Postoperative pulmonary complications [ Time Frame: 30 days ]Pulmonary complications after operation within 30 days
- Postoperative recovery index [ Time Frame: 7 days ]participants will be followed for the duration of hospital stay after operation, an expected average of 7 days
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): NCT02246153
|Contact: Guoxin Li, M.D., Ph.D.||+email@example.com|
|Contact: Hao Liu, M.D., PhDfirstname.lastname@example.org|
|Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, China, 510515|
|Contact: Guoxin Li, M.D., Ph.D. +86-138-0277-1450 email@example.com|
|Principal Investigator: Guoxin Li, M.D.,Ph.D.|
|Sub-Investigator: Jiang Yu, MD, PhD|
|Sub-Investigator: Yanfeng Hu, MD, PhD|
|Sub-Investigator: Tingyu Mou, MD, PhD|
|Sub-Investigator: Hao Liu, MD, PhD|
|Principal Investigator:||Guoxin Li, M.D., Ph.D.||Nanfang Hospital of Southern Medical University|