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

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ClinicalTrials.gov Identifier: NCT03385018
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 772 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2-arm randomized controlled study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Controlled Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Actual Study Start Date : April 5, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Laparoscopic group
Arm Description: Laparoscopic radical total gastrectomy with D2 (or D2-#10) lymph node dissection
Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach
  • 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

Active Comparator: Open group
Open radical total gastrectomy with D2 (or D2-#10) lymph node dissection
Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach
  • 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 Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385018


Contacts
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Contact: Woo Jin Hyung, MD, PhD +82-2-2228-2100 wjhyung@yuhs.ac

Locations
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Korea, Republic of
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Woo Jin Hyung, MD    +82-2-2228-2100    WJHYUNG@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03385018     History of Changes
Other Study ID Numbers: 4-2017-0940
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases