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Gastric CancerPhase 3NCT02980861

Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection

A Phase 3 study testing Laparoscopic total gastrectomy and Open total gastrectomy in people with Gastric Cancer, run by Chinese PLA General Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
Laparoscopic total gastrectomy and Open total gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
Jan 2017to Jun 2020
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
  • cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (AJCC) Cancer Staging Manual, 7th Edition.
  • Eastern Cooperative Oncology Group (ECOG): 0 or 1;
  • American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;
  • Written informed consent.

Who cannot join

  • Pregnant or breast-feeding women;
  • Severe mental disorder;
  • Previous upper abdominal surgery (except laparoscopic cholecystectomy);
  • Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;
  • Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
  • Other malignant disease within the past 5 years;
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  • Previous neoadjuvant chemotherapy or radiotherapy;
  • Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);
  • Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.

Trial locations and contacts

1 site in 1 country.

Hongqing Xi, Master contact

010-66938128

China1 site

  • Chinese PLA General Hospital

    Beijing, 100853

    Lin Chen, Master, 86-13801290395, chenlinbj@sina.com

Other trials in China

About this study

Official title: Laparoscopic Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial

Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.

Read the detailed description

Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however, complete removal of the No. 10 is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. However, laparoscopic total gastrectomy (LTG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. Therefore,the investigators aim to investigate the safety and feasibility of LTG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compare the early results of this procedure with open total gastrectomy (OTG).

Conditions
Gastric Cancer
Being tested
Laparoscopic total gastrectomy, Open total gastrectomy
Keywords
Gastric Cancer, Splenic Hilum Lymph Nodes Dissection, Gastrectomy
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic total gastrectomyProcedure or surgery

    Also called LTG

    When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.

  • Open total gastrectomyProcedure or surgery

    Also called OTG

    When the participants with advanced proximal gastric cancer are randomized in the open total gastrectomy(OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.

Study groups in NCT02980861
Study groupRoleWhat they receive
Laparoscopic total gastrectomyExperimentalParticipants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection.
Receives: Procedure: Laparoscopic total gastrectomy
Open total gastrectomyActive comparatorParticipants who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.
Receives: Procedure: Open total gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of group Splenic Hilum (No.10) lymph nodes harvested

    Measured: 7 days

Secondary outcomes (9)

  1. Early complication rate

    The early complication rate is defined as the event observed during operation

    Measured: 30 days

  2. Operative time

    Measured: Intraoperative

  3. Operative blood loss

    Measured: Intraoperative

  4. Time of splenic hilum lymph nodes dissection

    Measured: Intraoperative

  5. Number of total lymph nodes harvested

    Measured: 7 days

  6. Post-operative recovery course

    Time to first ambulation, flatus, liquid diet and duration of hospital stay are used to assess the postoperative recovery course

    Measured: 30 days

  7. 3-year disease free survival rate

    Measured: 3 years

  8. 3-year overall survival rate

    Measured: 3 years

  9. Quality of life

    It will be assessed by questionnaire (WHO quality of life-100)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionDec 2019 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02980861
Sponsor's protocol ID
Z161100000516237
Status last verified
Dec 2016
First submitted
30 Nov 2016
Last updated
6 Dec 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Bian S, Xi H, Wu X, Cui J, Ma L, Chen R, Wei B, Chen L. The Role of No. 10 Lymphadenectomy for Advanced Proximal Gastric Cancer Patients Without Metastasis to No. 4sa and No. 4sb Lymph Nodes. J Gastrointest Surg. 2016 Jul;20(7):1295-304. doi: 10.1007/s11605-016-3113-3. Epub 2016 Mar 3.

    PubMed 26940944

  • Guo X, Peng Z, Lv X, Cui J, Zhang K, Li J, Jin N, Xi H, Wei B, Chen L. Randomized controlled trial comparing short-term outcomes of laparoscopic and open spleen-preserving splenic hilar lymphadenectomy for advanced proximal gastric cancer: An interim report. J Surg Oncol. 2018 Dec;118(8):1264-1270. doi: 10.1002/jso.25262. Epub 2018 Oct 31.

    PubMed 30380145

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Laparoscopic total gastrectomy and Open total gastrectomy in people with Gastric Cancer, run by Chinese PLA General Hospital 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 5 inclusion and 9 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 6 Dec 2016. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Hongqing Xi, Master (010-66938128), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of group Splenic Hilum (No.10) lymph nodes harvested (time frame: 7 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 NCT02980861, 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 6 Dec 2016.

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