Efficacy of Laparoscopic Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric Cancer

Gastric Cancer Clinical Trial

— KLASS-02-RCT  

Official title:

Prospective Multicenter Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Subtotal Gastrectomy With D2 Lymph Node Dissection for Locally Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456598
• Other study ID #: AJIRB-MED-MDB-11-233
• Status: Completed
• Phase: N/A
• Start date: November 21, 2011
• Est. completion date: June 2, 2018

Study information

• Verified date: November 2018
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• It was confirmed that the laparoscopic surgery decreases the postoperative pain and reduces the recovery periods in the various surgical fields such as cholecystectomy and colectomy etc. Also, there are clinical evidences that the laparoscopic surgery is applicable to malignant tumor according to the development of surgical techniques and medical instruments.

• In case of early stage of gastric cancer, as the diverse clinical evidences, the gastrectomy has been commonly applied, however, the opening surgery is still applied for advanced gastric cancer due to lack of clinical evidence.

• In Korea, approximately 38% of patients who undergo surgery for gastric cancer are diagnosed by T2-T3 (AJCC 6th edition) (www.i-kgca.or.kr, National gastric cancer registration business in 2009). There are various clinical evidences to apply laparoscopic surgery to the patients, however, most of them are retrospective or cohort study results.

• For the clinical application of surgical treatment regarding locally advanced gastric cancer using laparoscopic surgical technique, it requires the confirmation of definite execution for laparoscopic gastrectomy and D2 lymph node dissection and the safety of surgery and oncological usefulness should be verified.

• In order for this, it is only possible to confirm through the comparison of short-term surgical results (complications, mortalities, operative time and duration of hospitalization etc) and long-term results (survival rates and recurrence rates etc) between laparoscopic surgery and opening surgery based on the multicenter large-sized randomized prospective study with current standard treatment.

Description:

Participating Surgeons

• Prior to this clinical trial, only the surgeons who are considered to have the standardization by participating the assignment entitled with "KLASS-02-QC: Standardization of D2 Lymphadenectomy and Surgical Quality Control for KLASS-02 Trial"(ClinicalTrials.gov No: NCT01283893).

Patients Registration

• It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.

• After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Ajou University clinical trial center.

Randomization

• The registration randomization should be done with 1:1 ratio for each researcher.

• Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table.

Procedure

• Operations are performed according to the allocated group.

Adjuvant Treatment

• If it is under Stage II and Stage III in the final postoperative pathology, the adjuvant chemotherapy based on 5-FU.

Evaluation of efficacy and safety

• 3-year Relapse free survival rate and overall survival rate of the patients who undergo laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.

• Analysis of recovery after laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.

• Postoperative complications of the patients who undergo laparoscopic and open subtotal gastrectomy and D2 lymph node dissection within postoperative 3 weeks and later.

• The quality of life at preoperative, postoperative 25 days and 1 years using recovery index such as recovery of postoperative intestinal hypermotility, meals and duration of hospitalization, EORTC-C30 and STO22 questionnaire between the patients who underwent laparoscopic and open subtotal gastrectomy and D2 lymph node dissection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1050
• Est. completion date: June 2, 2018
• Est. primary completion date: June 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• The patient from over 20 years to under 80 years

• The patient with the capability for ECOG (Eastern Cooperative Oncology Group performance status) is ranged between 0 and 1

• The patient included between ASA score (American society of anesthesiology) class I and III

• The patient who is diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy

• The patient who is diagnosed as locally advanced gastric cancer with the suspicious infiltration of over muscular layer without infiltration on adjacent organs, and without or with lymph node metastasis limited to perigastric or around stomach left gastric artery at the preoperative examination.

• The patient who is suitable for subtotal resection in the preoperative examination

• The patient who is fully explained about purpose of trial and contents prior to the participation into this study and signed on the informed consent approved by Institutional Review Board according to own opinion

Exclusion Criteria:

• The patient who shows distant metastasis under preoperative examination

• The patient with medical history for gastrectomy in the past

• The patient with complication (complete obstruction and perforation) by gastric cancer

• The patient who undergoes anticancer or radiologic therapy prior to the operation or who undergoes endoscopic submucous dissection for currently diagnosed gastric cancer

• The patient who undergoes surgery or anti-cancer radiologic therapy for primary cancer within 5 years

• Vulnerable patients (lack of capacity for decision making, pregnant women (or under planning))

• The patient who has participated into another clinical trial within recent 6 months or who is participating into another trial

• The patient with double cancer of activity and synchronization

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic gastrectomy
After laparoscopic observation, the possibility of surgery can be considered by examining inside of abdomen. The surgeon undergoes laparoscopic subtotal gastrectomy and D2 lymph node dissection After lymph node dissection, it is possible to undergo gastrectomy on appropriate part and reconstruction under small incision or laparoscopic view. As the reconstruction, one of the techniques like Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance.
• Open gastrectomy
After laparotomy, the possibility of surgery can be considered by examining inside of abdomen. The surgeon undergoes open subtotal gastrectomy and D2 lymph node dissection After lymph node dissection, one of the techniques likes Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance.

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery , SOON CHUN HYANG UNIVESITY HOSPITAL	Bucheon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Copyright National Cancer Center	Goyang-si
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun
Korea, Republic of	Incheon St, Mary's Hostpial, The Catholic University of Korea	Incheon
Korea, Republic of	Dong-A University Hospital	Pusan
Korea, Republic of	Department of Surgery, Seoul National University BUNDANG Hospital	Seongnam
Korea, Republic of	Department of surgery, GANGNAM SEVERANCE HOSPITAL	Seoul
Korea, Republic of	Department of Surgery, Seoul National University Hospital	Seoul
Korea, Republic of	EWHA Womans university medical center	Seoul
Korea, Republic of	Yeoeuido St. Mary's Hospital, The Catholic University of Korea	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b. — View Citation

Kim W, Song KY, Lee HJ, Han SU, Hyung WJ, Cho GS. The impact of comorbidity on surgical outcomes in laparoscopy-assisted distal gastrectomy: a retrospective analysis of multicenter results. Ann Surg. 2008 Nov;248(5):793-9. doi: 10.1097/SLA.0b013e3181887516. — View Citation

Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8. Erratum in: Surg Laparosc Endosc. 2013 Oct;23(5):480. — View Citation

Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. Erratum in: N Engl J Med. 2008 May 1;358(18):1977. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 year relapse free survival	In terms of locally advanced gastric cancer, to examine the non-inferiority of disease free sur-vival rate in laparoscopic subtotal gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open subtotal gastrectomy with D2 lymph node dissection	36 months
Secondary	Early postoperative complication	Early postoperative complication is defined as the events which occurs with-in postoperative 21 days, extension of hospitalization and rehospitaliation. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name and date of on-set (postoperatively) and treatment for complication.	3 weeks
Secondary	Postoperative mortality	It is defined as the death within postoperative 90 days regardless of postoperative reason. If the patient is transferred to other medication institutes with impossible condition for revocery be-fore death, it is regarded as death.	90 days
Secondary	Late postoperative complication	Late postoperative complication is defined the events which occurs after postoperative 21 days. It is necessary to evaluate the complication. it is required to record complication name and date of on-set (postoperatively) and treatment for complication.	36 months
Secondary	Postoperative recovery index	Postoperatively, the examiner evaluates the patient's recovery condition (gas exhaust) once a day. Evaluation items for patient's recovery condition: record the meal process once a day and inquire the pain score (10-scored scale) and blood test results during postoperative hospitalization.	4 weeks
Secondary	Postoperative quality of life	On preoperative, postoperative 3 weeks and postoperative 12 months, both EORTC-C30 and STO22 are analyzed with quality of life by following methods. In case of EORTC-C30, the analysis is undergone by classifying into 5 functional scales (physical, role, emotional, cognitive, and social fungtioning), 3 symptom scales (fatigue, pain and nausea, and vomiting), 1 global health status and 6 single items.	preoperative, 3 weeks, 12 months
Secondary	3 years overall survival	As one of the secondary endpoints, the overall survival rate in laparoscopic subtotal gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open subtotal gastrectomy with D2 lymph node dissection. The schedule of visit is based on every 3 months for 3 years. If subjects cannot visit every 3 months, the investigator can arrange the schedule. However, enrolled should visit every 6 months for 3 years.	6, 12, 18, 24, 30 and 36 months

External Links

•   Ajou University Hospital
•   Institutional Review Board, Ajou University Hospital
•   The Korean Gastric Cancer Association