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

Primary Purpose

Complications

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Laparoscopic gastrectomy
Open gastrectomy
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complications focused on measuring Laparoscopic gastrectomy, Advanced gastric cancer, Elderly patients, Morbidity, Mortality

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic gastrectomy

Open gastrectomy

Arm Description

Laparoscopy-assisted distal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.

Open distal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.

Outcomes

Primary Outcome Measures

Postoperative complication rate
30 day morbidity and mortality

Secondary Outcome Measures

Postoperative pulmonary complications
Pulmonary complications after operation within 30 days
Postoperative recovery index
participants will be followed for the duration of hospital stay after operation, an expected average of 7 days

Full Information

First Posted
September 15, 2014
Last Updated
January 7, 2017
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02246153
Brief Title
Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients
Official Title
Morbidity and Mortality of Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications
Keywords
Laparoscopic gastrectomy, Advanced gastric cancer, Elderly patients, Morbidity, Mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic gastrectomy
Arm Type
Experimental
Arm Description
Laparoscopy-assisted distal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Arm Title
Open gastrectomy
Arm Type
Active Comparator
Arm Description
Open distal gastrectomy with D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic gastrectomy
Other Intervention Name(s)
LDG
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Open gastrectomy
Other Intervention Name(s)
ODG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative complication rate
Description
30 day morbidity and mortality
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Postoperative pulmonary complications
Description
Pulmonary complications after operation within 30 days
Time Frame
30 days
Title
Postoperative recovery index
Description
participants will be followed for the duration of hospital stay after operation, an expected average of 7 days
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guoxin Li, M.D., Ph.D.
Phone
+86-138-0277-1450
Email
gzliguoxin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Liu, M.D., PhD
Phone
+86-138-2215-8578
Email
liuhaofbi@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D., Ph.D.
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D., Ph.D.
Phone
+86-138-0277-1450
Email
gzliguoxin@163.com
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D.,Ph.D.
First Name & Middle Initial & Last Name & Degree
Jiang Yu, MD, PhD
First Name & Middle Initial & Last Name & Degree
Yanfeng Hu, MD, PhD
First Name & Middle Initial & Last Name & Degree
Tingyu Mou, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hao Liu, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23850088
Citation
Yu J, Hu J, Huang C, Ying M, Peng X, Wei H, Jiang Z, Du X, Liu Z, Liu H, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. The impact of age and comorbidity on postoperative complications in patients with advanced gastric cancer after laparoscopic D2 gastrectomy: results from the Chinese laparoscropic gastrointestinal surgery study (CLASS) group. Eur J Surg Oncol. 2013 Oct;39(10):1144-9. doi: 10.1016/j.ejso.2013.06.021. Epub 2013 Jul 10.
Results Reference
background
PubMed Identifier
30430021
Citation
Luo J, Zhu Y, Liu H, Hu YF, Li TJ, Lin T, Chen T, Chen H, Chen XH, Yu J, Li GX. Morbidity and mortality of elderly patients with advanced gastric cancer after laparoscopy-assisted or open distal gastrectomy: a randomized-controlled trial. Gastroenterol Rep (Oxf). 2018 Nov;6(4):317-319. doi: 10.1093/gastro/goy013. Epub 2018 May 17.
Results Reference
derived
Links:
URL
http://www.fimmu.com/index_com.html
Description
Southern Medical University, China
URL
http://www.nfyy.com/
Description
Nanfang Hospital, China
URL
http://www.caca.org.cn/
Description
Chinese Anti-Cancer Association

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

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