Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Guoxin Li, Nanfang Hospital of Southern Medical University

Brief Summary:
  • 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
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
  • After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
  • The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy.
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
  • After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, open distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
  • The type of reconstruction will be selected according to the surgeon's experience.
Other Name: ODG




Primary Outcome Measures :
  1. Postoperative complication rate [ Time Frame: 30 days ]
    30 day morbidity and mortality


Secondary Outcome Measures :
  1. Postoperative pulmonary complications [ Time Frame: 30 days ]
    Pulmonary complications after operation within 30 days

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 65 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
  • Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
  • Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  • ASA (American Society of Anesthesiology) score class I, II, or III
  • Written informed consent

Exclusion Criteria:

  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  • Exclude the early gastric cancer feasible for ESD
  • Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
  • History of other malignant disease within past five years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1<50% of predicted values

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Guoxin Li, M.D., Ph.D. +86-138-0277-1450 gzliguoxin@163.com
Contact: Hao Liu, M.D., PhD +86-138-2215-8578 liuhaofbi@163.com

Locations
Layout table for location information
China
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, China, 510515
Contact: Guoxin Li, M.D., Ph.D.    +86-138-0277-1450    gzliguoxin@163.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         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
Layout table for investigator information
Principal Investigator: Guoxin Li, M.D., Ph.D. Nanfang Hospital of Southern Medical University

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Guoxin Li, M.D.,Ph.D., F.R.C.S., Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02246153    
Other Study ID Numbers: NFEC-2014-067
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Keywords provided by Guoxin Li, Nanfang Hospital of Southern Medical University:
Laparoscopic gastrectomy
Advanced gastric cancer
Elderly patients
Morbidity
Mortality
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases