Gastric CancerSWEETNCT02464215
Effect of Laparoscopy-Assisted Distal Gastrectomy for Locally Advanced Gastric Cancer
A study testing open surgery and laparoscopic surgery in people with Gastric Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2 radical surgery for distal advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- open surgery and laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2014to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- open surgery, laparoscopic surgery
- Keywords
- gastric cancer, D2, laparoscopic, open, surgery
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open surgeryProcedure or surgery
Also called ODG
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.
laparoscopic surgeryProcedure or surgery
Also called LADG
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.
| Study group | Role | What they receive |
|---|---|---|
| open surgery | Active comparator | Conventional procedure,Open surgery Receives: Procedure: open surgery |
| laparoscopic surgery | Experimental | Minimum invasive procedure，Laparoscopic surgery Receives: Procedure: laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication rate
Surgical complications within 30 days after surgery
Measured: 30 days
Secondary outcomes (1)
3-year disease free survival rate
3-year disease free survival rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start1 Mar 2014
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital, Beijing Shijitan Hospital, Capital Medical University, Xuanwu Hospital, Beijing, Beijing Tongren Hospital
- Responsible party
- Principal investigator, Xiangqian Su, Peking University Cancer Hospital & Institute
- Investigators
- Xiangqian Su, professor, Principal investigator, Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464215
- Sponsor's protocol ID
- XM201309
- Acronym
- SWEET
- Status last verified
- May 2020
- First submitted
- 1 Jun 2015
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 38981881Wang 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.
PubMed 30386984
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy(ODG) for Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02464215
- Acronym / sponsor ID
- SWEET / XM201309
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, D2, laparoscopic, open, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Beijing Friendship Hospital, Beijing Shijitan Hospital, Capital Medical University, Xuanwu Hospital, Beijing, Beijing Tongren Hospital
- Study start
- 1 Mar 2014
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open surgery | Active comparator | Procedure: open surgeryConventional procedure,Open surgery |
| laparoscopic surgery | Experimental | Procedure: laparoscopic surgeryMinimum invasive procedure，Laparoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open surgeryAlso: ODGSubtotal 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. | Procedure or surgery | open surgery |
| laparoscopic surgeryAlso: LADGPatients 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. | Procedure or surgery | laparoscopic surgery |
Primary outcome
Postoperative complication rate
Time frame: 30 days
Surgical complications within 30 days after surgery
1 secondary outcome
3-year disease free survival rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 38981881Xing 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.
- Derived from this study: PubMed 30386984Wang 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangqian Su, professor principal investigator
Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open surgery and laparoscopic surgery in people with Gastric Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complication rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02464215, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.