Effect of Laparoscopy-Assisted Distal Gastrectomy for Locally Advanced Gastric Cancer (SWEET)

May 9, 2020 updated by: Xiangqian Su, Peking University Cancer Hospital & Institute

Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy(ODG) for Locally Advanced Gastric Cancer

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In both arms,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 (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. As a general rule, Billroth I or BillrothII methods will be used for gastric reconstruction for all cases. For anastomosis, absorbable suture is used. Anastomotic diameter is 5~6 cm length. Drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.

Study Type

Interventional

Enrollment (Actual)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
  2. Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
  3. Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
  4. Patient who was treated because of systemic inflammatory disease
  5. Pregnant patient or lactating women
  6. Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis
  7. serious mental illness
  8. gastric surgery (including for gastric ESD / EMR)
  9. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm)
  10. other malignant diseases in 5 years
  11. have unstable angina or myocardial infarction within six months
  12. have cerebral infarction or cerebral hemorrhage within 6 months
  13. sustained systemic glucocorticoid treatment history within 1 month
  14. have other diseases needed operative treatment at the same time
  15. complications (bleeding, perforation, obstruction) required emergency surgery
  16. Pulmonary function tests FEV1 <50% of predicted value.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: open surgery
Conventional procedure,Open surgery
Procedure: open surgery
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.
Other Names:
  • ODG
EXPERIMENTAL: laparoscopic surgery
Minimum invasive procedure，Laparoscopic surgery
Procedure: laparoscopic surgery
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.
Other Names:
  • LADG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complication rate
Time Frame: 30 days
Surgical complications within 30 days after surgery
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease free survival rate
Time Frame: 3 years
3-year disease free survival rate
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Collaborators

Beijing Friendship Hospital
Xuanwu Hospital, Beijing
Beijing Tongren Hospital
Beijing Shijitan Hospital, Capital Medical University

Investigators

  • Principal Investigator: Xiangqian Su, professor, Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

August 31, 2020

Study Completion (ANTICIPATED)

August 31, 2020

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (ESTIMATE)

June 8, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 9, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XM201309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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