NCT02980861

Brief Summary

Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.

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
200

participants targeted

Target at P25-P50 for phase_3 gastric-cancer

Timeline
Completed

Started Jan 2017

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

First Submitted

Initial submission to the registry

November 30, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

2.9 years

First QC Date

November 30, 2016

Last Update Submit

December 5, 2016

Conditions

Gastric Cancer

Keywords

Gastric CancerSplenic Hilum Lymph Nodes DissectionGastrectomy

Outcome Measures

Primary Outcomes (1)

  • Number of group Splenic Hilum (No.10) lymph nodes harvested

    7 days

Secondary Outcomes (9)

  • Early complication rate

    30 days

  • Operative time

    Intraoperative

  • Operative blood loss

    Intraoperative

  • Time of splenic hilum lymph nodes dissection

    Intraoperative

  • Number of total lymph nodes harvested

    7 days

  • +4 more secondary outcomes

Study Arms (2)

Laparoscopic total gastrectomy

EXPERIMENTAL

Participants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection.

Procedure: Laparoscopic total gastrectomy

Open total gastrectomy

ACTIVE COMPARATOR

Participants who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.

Procedure: Open total gastrectomy

Interventions

Laparoscopic total gastrectomyPROCEDURE

When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.

Also known as: LTG
Laparoscopic total gastrectomy
Open total gastrectomyPROCEDURE

When the participants with advanced proximal gastric cancer are randomized in the open total gastrectomy(OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.

Also known as: OTG
Open total gastrectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
  • cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (AJCC) Cancer Staging Manual, 7th Edition.
  • Eastern Cooperative Oncology Group (ECOG): 0 or 1;
  • American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;
  • Written informed consent.

You may not qualify if:

  • Pregnant or breast-feeding women;
  • Severe mental disorder;
  • Previous upper abdominal surgery (except laparoscopic cholecystectomy);
  • Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;
  • Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
  • Other malignant disease within the past 5 years;
  • Previous neoadjuvant chemotherapy or radiotherapy;
  • Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);
  • Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

Location

Related Publications (2)

  • Bian S, Xi H, Wu X, Cui J, Ma L, Chen R, Wei B, Chen L. The Role of No. 10 Lymphadenectomy for Advanced Proximal Gastric Cancer Patients Without Metastasis to No. 4sa and No. 4sb Lymph Nodes. J Gastrointest Surg. 2016 Jul;20(7):1295-304. doi: 10.1007/s11605-016-3113-3. Epub 2016 Mar 3.

    PMID: 26940944BACKGROUND

  • Guo X, Peng Z, Lv X, Cui J, Zhang K, Li J, Jin N, Xi H, Wei B, Chen L. Randomized controlled trial comparing short-term outcomes of laparoscopic and open spleen-preserving splenic hilar lymphadenectomy for advanced proximal gastric cancer: An interim report. J Surg Oncol. 2018 Dec;118(8):1264-1270. doi: 10.1002/jso.25262. Epub 2018 Oct 31.

    PMID: 30380145DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Lin Chen

    the Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongqing Xi, Master

CONTACT

010-66938128

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
Director

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 2, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

December 6, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)