NCT02464215

Brief Summary

The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2 radical surgery for distal advanced 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
440

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable gastric-cancer

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

March 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

6.5 years

First QC Date

June 1, 2015

Last Update Submit

May 9, 2020

Conditions

Gastric Cancer

Keywords

gastric cancerD2laparoscopicopensurgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative complication rate

    Surgical complications within 30 days after surgery

    30 days

Secondary Outcomes (1)

  • 3-year disease free survival rate

    3 years

Study Arms (2)

open surgery

ACTIVE COMPARATOR

Conventional procedure,Open surgery

Procedure: open surgery

laparoscopic surgery

EXPERIMENTAL

Minimum invasive procedure，Laparoscopic surgery

Procedure: laparoscopic surgery

Interventions

open surgeryPROCEDURE

Subtotal gastectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dessection(around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically.

Also known as: ODG
open surgery
laparoscopic surgeryPROCEDURE

Patients in this arm undergo radical resection of gastric cancer in laparoscopic surgery.10 mm trocar under umbilicus, 12 mm and 5 mm trocar at the right flank area are inserted into abdominal wall. Another two 5 mm trocar are inserted into the both midline of subcostal line. The devices for operation are inserted through the trocars. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. Dissected stomach and lymph node are collected through additional 5-10 cm incision at the preexisting epigastric incision.

Also known as: LADG
laparoscopic surgery

Eligibility Criteria

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

You may qualify if:

  • Age: older than 18 years old，including 18 years old
  • Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma)
  • Cancer core: located at lower part of stomach
  • Preoperative cancer stage : cT2-4a,N0-3,M0 (according to AJCC-7th TNM staging)
  • surgery：subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection
  • ASA score: ≤ 3;ECOG performance status 0/1
  • Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)

You may not qualify if:

  • Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
  • Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
  • Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
  • Patient who was treated because of systemic inflammatory disease
  • Pregnant patient or lactating women
  • Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis
  • serious mental illness
  • gastric surgery (including for gastric ESD / EMR)
  • imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
  • other malignant diseases in 5 years
  • have unstable angina or myocardial infarction within six months
  • have cerebral infarction or cerebral hemorrhage within 6 months
  • sustained systemic glucocorticoid treatment history within 1 month
  • have other diseases needed operative treatment at the same time
  • complications (bleeding, perforation, obstruction) required emergency surgery
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (2)

  • Xing J, Cai J, Wang X, Zhang N, An D, Li F, Cui M, Niu L, Gao C, Fan Q, Ren S, Zhang Z, Su X; SWEET trial group. Long-term outcomes of laparoscopic versus open distal gastrectomy for patients with advanced gastric cancer in North China: a multicenter randomized controlled trial. Surg Endosc. 2024 Sep;38(9):4976-4985. doi: 10.1007/s00464-024-10952-2. Epub 2024 Jul 9.

    PMID: 38981881DERIVED

  • Wang Z, Xing J, Cai J, Zhang Z, Li F, Zhang N, Wu J, Cui M, Liu Y, Chen L, Yang H, Zheng Z, Wang X, Gao C, Wang Z, Fan Q, Zhu Y, Ren S, Zhang C, Liu M, Ji J, Su X. Short-term surgical outcomes of laparoscopy-assisted versus open D2 distal gastrectomy for locally advanced gastric cancer in North China: a multicenter randomized controlled trial. Surg Endosc. 2019 Jan;33(1):33-45. doi: 10.1007/s00464-018-6391-x. Epub 2018 Nov 1.

    PMID: 30386984DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Conversion to Open SurgeryLaparoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Xiangqian Su, professor

    Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 8, 2015

Study Start

March 1, 2014

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

May 12, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

Locations

CN(1)