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Gastric CancerNCT01345773

Incidence of Venous Thromboembolism Following Surgery in Patients With Gastric Cancer

An observational study of Gastric Cancer and Venous Thromboembolism, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Venous thromboembolism (VTE) has considerably harmful effects on morbidity and mortality of cancer patients. Several guidelines recommendations have been made about the use of anticoagulation for the prevention and treatment of VTE in Western patients with cancer. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Gastric surgery
Type of treatment
Surgery or procedure
How many people
375 participants
Where
1 siteSouth Korea
Study dates
May 2010to Sep 2011
Phase
Observational
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with gastric cancer receiving curative or palliative gastric cancer surgery

Who may be able to join

  • Histologically confirmed adenocarcinoma of stomach or gastroesophageal junction
  • Age ≥ 20 years
  • Patients receiving curative or palliative abdominal surgery (lasting ≥ 30 minutes) (both open and laparoscopic surgery will be included)

Who cannot join

  • No histological confirmation
  • Patients who already have VTE (or pulmonary embolism) at the screening periods of this study
  • Past medical history of VTE or pulmonary embolism
  • Patients with the history of other cancer (Patients who were disease-free for > 5 years from previous other cancer is allowed to be included in this study)
  • Patients with thrombophilia or other comorbidities requiring anticoagulation (i.e. atrial fibrillation or cerebral infarct requiring anticoagulation

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

Other trials in South Korea

About this study

Official title: Incidence of Venous Thromboembolism Following Surgery in Patients With Gastric Cancer; a Prospective Study

Venous thromboembolism (VTE) has considerably harmful effects on morbidity and mortality of cancer patients. Several guidelines recommendations have been made about the use of anticoagulation for the prevention and treatment of VTE in Western patients with cancer. In Western VTE guidelines, all solid cancer patients receiving abdominal major surgery are strongly recommended to receive pharmacologic prophylactic anticoagulation such as low molecular weight heparin (LMWH) in the perioperative periods. These guideline recommendations are based on high incidence of postoperative VTE development in Western cancer patients. However, there have been many cumulative data about the effect of different ethnicity on the VTE development and more and more investigators and clinicians admit that Asian ethnicity has lower incidence of VTE than Western ethnicity. Therefore, it may not be advisable to apply Western guidelines as it is to the clinical situation of Asian cancer patients.

Although gastric cancer is the common cancer in Asia, there is no prospective data on the incidence of VTE development during the postoperative period of gastric cancer surgery. In other words, Asian doctors including Korean clinicians don't know the exact incidence of surgery-related VTE. From their clinical experiences, most Korean surgeons think that the incidence of postoperative VTE development is rare. They also have much concern about the complications such as bleeding that might be caused by routine use of pharmacologic thromboprophylaxis during the perioperative periods. Therefore, in most clinical situation, Korean surgeons do not perform perioperative pharmacologic thromboprophylaxis using LMHW. Considering these clinical situations in Korea, the uncritical acceptance of Western guidelines is inappropriate. The necessity of pharmacologic thrombo-prophylaxis can be answered only from the results of the prospective study on the incidence of postoperative VTE development after gastric cancer surgery. Moreover, current surgical trend in cancer patients is minimally invasive approach such as laparoscopic surgery. However, the necessity of pharmacologic thromboprophylaxis in patients receiving laparoscopic cancer surgery has not been evaluated even in Western countries. Western guidelines also cannot exactly answer whether pharmacologic thromboprophylaxis is really necessary in cancer patients receiving laparoscopic cancer surgery. On above backgrounds, this study was designed.

Being tested
Gastric surgery
Medical subject headings
Stomach Neoplasms, Venous Thromboembolism

What participants receive

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

  • Gastric surgeryProcedure or surgery

    Patients receiving gastric cancer surgery will be prospectively observed for the development of venous thromboembolism

Study groups in NCT01345773
Study groupRoleWhat they receive
Patients receiving gastric cancer surgeryNot described
Receives: Procedure: Gastric surgery

What is being measured

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

  1. The incidence of symptomatic or asymptomatic VTE

    To evaluate the incidence of symptomatic or asymptomatic VTE detected by Doppler venous ultrasound during postoperative periods in patients with gastric cancer receiving surgery

    Measured: 5~12 days after the gastric cancer surgery (by doppler US) or the follow-up period of postoperative 1 month

Secondary outcomes (1)
  1. Risk factors for the development of VTE

    To identify risk factors for the development of VTE in this population

    Measured: 5~12 days after the gastric cancer surgery (by doppler US) or the follow-up period of postoperative 1 month

Timeline

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

  1. First posted2 May 2011 (estimated)
  2. Study startMay 2010
  3. Primary completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01345773
Sponsor's protocol ID
GC-VTE-01
Status last verified
Nov 2011
First submitted
29 Apr 2011
Last updated
17 Nov 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer and Venous Thromboembolism, run by Seoul National University Bundang Hospital at 1 site in South Korea.

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 Nov 2011. 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 South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The incidence of symptomatic or asymptomatic VTE (time frame: 5~12 days after the gastric cancer surgery (by doppler US) or the follow-up period of postoperative 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Nov 2011.

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