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NCT Number: NCT01804998

Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy

Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. For last two years, multicenter quality control study (Phase II) has been performed in Korea and tolerable results were observed. Based on these results, multicenter phase III trial is required to validate the clinical role of laparoscopic sentinel lymph node biopsy.

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Key information

Conditions

Early Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chonnam National University Hwasun Hospital, Hwasun, Chonnam, South Korea

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About this study

The final analyses include the modified intention to treatment analysis (full analysis set) and Per Protocol analysis (including patients who underwent assigned surgery without agreement withdrawal).

  • Injection of tracer and sentinel basin dissection
  • Tracer: Tc 99m HSA (Human serum albumin, 2ml, 0.1mCi/ml) + ICG (indocyanine green, 2ml, 5mg/ml)
  • Endoscopic injection of tracer on 4 sites around gastric cancer
  • Identification of sentinel basin using laparoscopic probe (Neoprobe)
  • Laparoscopic sentinel basin dissection and identification of sentinel node at back table
  • Surgical considerations
  • If positive sentinel nodes were diagnosed in frozen section, conventional gastrectomy is performed.
  • If micrometastasis or isolate tumor cells in sentinel basin lymph nodes were diagnosed in the permanent pathology, re-operation of conventional gastrectomy is not performed.
  • However, re-operation of converntional gastrectomy should be performed in case of macrometastasis, deep and lateral margin positive, more than pT2 lesion in the permanent pathology.
  • H.pylori eradication - There was no clear evidence that H.pylori eradication reduced development of metachronous gastric cancer. H.pylori eradication was planned to perform according to physician's decision or patient's need. However, recently, the effect of H.pylori eradication in development of metachronous gastric cancer was published in NEJM (Choi et al. 2018). Therefore, from now on, H. pylori eradication will be recommended to enrolled patients with H.pylori.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • single lesion of adenocarcinoma in preoperative endoscopic biopsy
  • clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography
  • tumor size: less than 3cm
  • location: 2cm far from the pylorus or cardia
  • aged 20 to 80
  • ECOG 0 or 1
  • patient who signed the agreement
  • patient who is suspected to underwent laparoscopy assisted gastrectomy

Exclusion criteria

  • indication of endoscopic submucosal resection
  • inoperable due to poor cardiac, pulmonary function
  • pregnant
  • having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen
  • diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer

Treatment and study plan

Laparoscopic Sentinel Node Biopsy

Procedure

Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in the experimental arm.

Laparoscopy Assisted Gastrectomy

Procedure

In the control arm, laparoscopy assisted gastrectomy with lymph node dissection (D1+ or more) will be performed.

Primary outcomes

  1. 3 year disease free survival rate

    Time frame: 3 years after surgery

    A total of enrollment period is suspected to be four years and patients will be followed up for five years. However, primary end point is 3 year disease free survival and we can analyze survival data at three year later from when the last enrolled patients underwent intervention.

Secondary outcomes

  1. postoperative morbidity and mortality

    Time frame: 30 days after surgery

    We will collect morbidity and mortality data for postoperative 30 days. Therefore, this end point will be completed one month later from when the last enrolled patients underwent intervention.

  2. scores of global health status scale, functional scales, and symptom scales/items of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22

    Time frame: 3 years

    Survey for quality of life will be performed regularly for three years after surgery. Measurement tool is the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22. In EORTC QLQ C30, there are 1 global health status scale, 5 functonal scales, and 9 symptom scales/items. EORTC QLQ STO22 includes 5 symptom scales and 4 single items. Each scale and item ranges 0 to 100. Higher score of global health status and functinoal scales indicate better quality of life and lower score of symptom scales indicates better quality of life. There is no summed score in these questionnaires.

  3. 5 year disease free survival rate

    Time frame: 5 years after surgery

    A total of enrollment period is suspected to be four years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention

  4. 5 year overall survival rate

    Time frame: 5 years after surgery

    A total of enrollment period is suspected to be four years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention

  5. 3 year recurrence free survival rate

    Time frame: 3 years after surgery

    A total of enrollment period is suspected to be four years and patients will be followed up for five years. However, primary end point is 3 year disease free survival and we can analyze survival data at three year later from when the last enrolled patients underwent intervention.

  6. 3 year disease specific death rate

    Time frame: 3 years after surgery

    A total of enrollment period is suspected to be four years and patients will be followed up for five years. However, primary end point is 3 year disease free survival and we can analyze survival data at three year later from when the last enrolled patients underwent intervention.

  7. 3 year overall survival rate

    Time frame: 3 years after surgery

    3 years after surgery

  8. 5 year recurrence free survival rate

    Time frame: 5 years after surgery

    A total of enrollment period is suspected to be four years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention.

  9. 5 year disease specific death rate

    Time frame: 5 years after surgery

    A total of enrollment period is suspected to be four years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer

Important dates

Study start
2013
Primary completion
2020
Study completion
2021
First posted
Mar 5, 2013
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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