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NCT Number: NCT03385018

Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)

Although Laparoscopic gastrectomy for both early and locally advanced gastric cancer has gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric cancer is still limited to some experienced surgeons, because of its technical difficulties in D2 lymph node dissection and anastomoses.

Some retrospective and cohort studies regarding laparoscopic total gastrectomy with lymph node dissection suggested the likelihood of application of laparoscopic surgery for proximal gastric cancer. However, there has been no randomized clinical trial comparing results of laparoscopic total gastrectomy with D2 lymph node dissection with open conventional surgery.

Therefore, we aimed to verify the efficacy of laparoscopic total gastrectomy with D2(D2-10) lymph node dissection, technical and oncologic safety compared with open surgery via multicenter randomized clinical trial.

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Key information

Conditions

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

Department of Surgery, Yonsei University College of Medicine, Seoul, Korea

Seoul, 120-752, South Korea

Location status: Recruiting

Location contact

Woo Jin Hyung, MD

CONTACT

[email protected]

+82-2-2228-2100

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are over 20 and below 80 years old
  • Patients who have performance status of ECOG 0 or 1
  • Patients with American Society of Anesthesiology score of class I to III
  • Patients who are diagnosed with gastric adenocarcinoma not involving Z-line by endoscopy with biopsy
  • Patients with tumors which can be curatively resected by total gastrectomy with lymph node dissection based on preoperative study
  • Patients who have primary gastric carcinoma invaded into over muscle propria, and not into adjacent organ in preoperative studies (cT2 ~ cT4a)
  • Patients who have no metastasis to lymph nodes or limited metastasis to perigastric lymph node metastasis in preoperative studies (cN0 ~ cN2)
  • Patients who agree with participating in the clinical study with informed consents
  • Patients who can be followed for at least 3 years after study enrollment

Exclusion criteria

  • Patients who have possibility of distant metastasis in preoperative studies
  • Patients who have history of gastric resection with any cause
  • Patients who have complications (bleeding or obstruction) of gastric cancer
  • Patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer
  • Patients who are diagnosed and treated with other malignancies within 5 years
  • Vulnerable patients
  • Patients who participating or participated in other clinical trial within 6 months

Treatment and study plan

Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach

Procedure
  • Total gastrectomy with D2(D2-10) lymph node dissection by laparoscopic approach
  • The number of trocars is 6 or less
  • Roux-en-Y esophagojejunostomy with any stapling method
  • Enough(negative) margin from tumor
  • LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined
  • Washing cytology
  • Frozen biopsy for surgical margin at surgeons discretion
  • Complete omentectomy for grossly serosa-involved tumor
  • Combined organ resection only in cholecystectomy and splenectomy
  • Indwelling nasogastric tube and drainage catheter at surgeons discretion
  • D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection

Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach

Procedure
  • Total gastrectomy with D2(D2-10) lymph node dissection by open conventional approach
  • Roux-en-Y esophagojejunostomy with any stapling method
  • Enough(negative) margin from tumor
  • LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined
  • Washing cytology
  • Frozen biopsy for surgical margin at surgeons discretion
  • Complete omentectomy for grossly serosa-involved tumor
  • Indwelling nasogastric tube and drainage catheter at surgeons discretion
  • D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection

Primary outcomes

  1. 3 year relapse-free survival

    Time frame: 3 years after surgery

    Non-inferiority of 3 year relapse-free survival rate after laparoscopic radical total gastrectomy and lymphadenectomy for locally advanced gastric cancer comparing with open conventional surgery.

    The "event" of relapse-free survival is defined as "recurrence" after 4 weeks of operation.

    The "censoring" is defined as non-traceable patient who cannot be confirmed with recurrence or patient who are alive without recurrence until follow-up.

    The "relapse-free survival time" is defined as the time from surgery to "event" or "censoring".

Secondary outcomes

  1. 3 year overall survival rate

    Time frame: 3 years after surgery

  2. 5 year relapse-free and overall survival

    Time frame: 5 years after surgery

  3. Morbidity (early period)

    Time frame: from Operation day until POD 21

  4. Morbidity (late period)

    Time frame: from POD (Post-Operative Day) 22 until 5 years after surgery

  5. Mortality

    Time frame: at POD 30

    death with any cause

  6. Mortality

    Time frame: at POD 90

    death with any cause

  7. Quality of life(EORTC QLQ-C30)

    Time frame: at POD 21

    Quality of life measured by EORTC QLQ-C30(Version 3) The questionnaire was designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of 5 multiitem scales (physical, role, social, emotional and cognitive functioning) and 9 single items (pain, fatigue, financial impact, appetite loss, nausea/vomiting, diarrhea, constipation, sleep disturbance and quality of life).

  8. Quality of life(EORTC QLC STO22)

    Time frame: at POD 21

    Quality of life measured by EORTC QLC STO22. The EORTC QLQ-STO 22 module contains 22 items in a similar layout and response format to the EORTC QLQ-C30. The hypothesised scale structure of the module consists of five scales (dysphagia, eating restrictions, pain, reflux and anxiety) and three single items (dry mouth, body image and hair loss).

  9. Quality of life(EORTC QLQ-C30)

    Time frame: 3 months after surgery

    Quality of life measured by EORTC QLQ-C30(Version 3)

  10. Quality of life(EORTC QLC STO22)

    Time frame: 3 months after surgery

    Quality of life measured by EORTC QLC STO22. The EORTC QLQ-STO 22 module contains 22 items in a similar layout and response format to the EORTC QLQ-C30. The hypothesised scale structure of the module consists of five scales (dysphagia, eating restrictions, pain, reflux and anxiety) and three single items (dry mouth, body image and hair loss).

  11. Quality of life(EORTC QLQ-C30)

    Time frame: 12 months after surgery

    Quality of life measured by EORTC QLQ-C30(Version 3)

  12. Quality of life(EORTC QLC STO22)

    Time frame: 12 months after surgery

    Quality of life measured by EORTC QLC STO22. The EORTC QLQ-STO 22 module contains 22 items in a similar layout and response format to the EORTC QLQ-C30. The hypothesised scale structure of the module consists of five scales (dysphagia, eating restrictions, pain, reflux and anxiety) and three single items (dry mouth, body image and hair loss).

Study contacts

Contact information is provided by the study sponsor or research team.

Woo Jin Hyung, MD, PhD

CONTACT

[email protected]

+82-2-2228-2100

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Multicenter Randomized Controlled Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)

Important dates

Study start
2018
Primary completion
2022
Study completion
2027
First posted
Dec 28, 2017
Registry last updated
Mar 19, 2019

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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