ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02464215
Recruitment Status : Active, not recruiting
First Posted : June 8, 2015
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Beijing Friendship Hospital
Beijing Shijitan Hospital
Xuanwu Hospital, Beijing
Beijing Tongren Hospital
Information provided by (Responsible Party):
Xiangqian Su, Beijing Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: open surgery Procedure: laparoscopic surgery Not Applicable

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  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy(ODG) for Locally Advanced Gastric Cancer
Study Start Date : March 2014
Actual Primary Completion Date : August 31, 2017
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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 Name: 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 Name: LADG




Primary Outcome Measures :
  1. Postoperative complication rate [ Time Frame: 30 days ]
    Surgical complications within 30 days after surgery


Secondary Outcome Measures :
  1. 3-year disease free survival rate [ Time Frame: 3 years ]
    3-year disease free survival rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464215


Locations
China, Beijing
Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Beijing Cancer Hospital
Beijing Friendship Hospital
Beijing Shijitan Hospital
Xuanwu Hospital, Beijing
Beijing Tongren Hospital
Investigators
Principal Investigator: Xiangqian Su, professor Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute

Responsible Party: Xiangqian Su, Principal Investigator, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT02464215     History of Changes
Other Study ID Numbers: XM201309
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Xiangqian Su, Beijing Cancer Hospital:
gastric cancer
D2
laparoscopic
open
surgery

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases