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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
open surgery
laparoscopic surgery
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, D2, laparoscopic, open, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

open surgery

laparoscopic surgery

Arm Description

Conventional procedure,Open surgery

Minimum invasive procedure，Laparoscopic surgery

Outcomes

Primary Outcome Measures

Postoperative complication rate
Surgical complications within 30 days after surgery

Secondary Outcome Measures

3-year disease free survival rate
3-year disease free survival rate

Full Information

First Posted
June 1, 2015
Last Updated
May 9, 2020
Sponsor
Peking University Cancer Hospital & Institute
Collaborators
Beijing Friendship Hospital, Beijing Shijitan Hospital, Capital Medical University, Xuanwu Hospital, Beijing, Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02464215
Brief Title
Effect of Laparoscopy-Assisted Distal Gastrectomy for Locally Advanced Gastric Cancer
Acronym
SWEET
Official Title
Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy(ODG) for Locally Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2014 (undefined)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute
Collaborators
Beijing Friendship Hospital, Beijing Shijitan Hospital, Capital Medical University, Xuanwu Hospital, Beijing, Beijing Tongren Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, D2, laparoscopic, open, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Actual)

8. Arms, Groups, and Interventions

Arm Title
open surgery
Arm Type
Active Comparator
Arm Description
Conventional procedure,Open surgery
Arm Title
laparoscopic surgery
Arm Type
Experimental
Arm Description
Minimum invasive procedure，Laparoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
open surgery
Other Intervention Name(s)
ODG
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgery
Other Intervention Name(s)
LADG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative complication rate
Description
Surgical complications within 30 days after surgery
Time Frame
30 days
Secondary Outcome Measure Information:
Title
3-year disease free survival rate
Description
3-year disease free survival rate
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 Pulmonary function tests FEV1 <50% of predicted value.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangqian Su, professor
Organizational Affiliation
Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
30386984
Citation
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.
Results Reference
derived

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

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