NCT02246153

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
202

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

2.9 years

First QC Date

September 15, 2014

Last Update Submit

January 7, 2017

Conditions

Complications

Keywords

Laparoscopic gastrectomyAdvanced gastric cancerElderly patientsMorbidityMortality

Outcome Measures

Primary Outcomes (1)

  • Postoperative complication rate

    30 day morbidity and mortality

    30 days

Secondary Outcomes (2)

  • Postoperative pulmonary complications

    30 days

  • Postoperative recovery index

    7 days

Study Arms (2)

Laparoscopic gastrectomy

EXPERIMENTAL

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

Procedure: Laparoscopic gastrectomy

Open gastrectomy

ACTIVE COMPARATOR

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

Procedure: Open gastrectomy

Interventions

Laparoscopic gastrectomyPROCEDURE

* 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.

Also known as: LDG
Laparoscopic gastrectomy
Open gastrectomyPROCEDURE

* 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.

Also known as: ODG
Open gastrectomy

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, 510515, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23850088BACKGROUND

  • 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.

    PMID: 30430021DERIVED

Related Links

Study Officials

  • Guoxin Li, M.D., Ph.D.

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoxin Li, M.D., Ph.D.

CONTACT

+86-138-0277-1450gzliguoxin@163.com

Hao Liu, M.D., PhD

CONTACT

+86-138-2215-8578liuhaofbi@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.,Ph.D., F.R.C.S.

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 22, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

CN(1)