Assessment of a Robotic Distal Gastrectomy on Non-inferiority of N2 Area Nodal Dissection

Gastric Cancer Clinical Trial

— AaRon  

Official title:

Assessment of a Robotic Distal Gastrectomy on Non-inferiority of N2 Area Nodal Dissection for Clinical Stage II or III Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02572050
• Other study ID #: NCC2015-0191
• Status: Recruiting
• Phase: Phase 2
• First received: October 6, 2015
• Last updated: April 18, 2016
• Start date: October 2015
• Est. completion date: December 2021

Study information

• Verified date: April 2016
• Source: National Cancer Center, Korea
• Contact: Young-Woo Kim, PhD
• Phone: +821088691635
• Email: gskim[@]ncc.re.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Designed as a single arm multi-center prospective phase II trial, which evaluates the number of dissected lymph nodes in the N2-area as a surrogate parameter for adequate D2 lymphadenectomy in robotic distal gastrectomy (RDG) for clinical stage II or III gastric cancer.

Description:

The number of retrieved LNs in the N2 area after RDG is going to be calculated according to the pathology reports and comparative analysis to a historic group undergone open surgery for clinical stage II or III gastric cancer at the NCC Korea last year.

METHODS AGAINST BIAS Minimizing selection bias: After initiation of the study, all patients will be screened consecutively and all eligible patients will be asked to enrol in the trial. The trial is designed as a prospective multi-center phase II trial. Patients are going to be allocated to RAG after giving signed consent after sufficient consideration time.

Minimizing performance bias: The study is planned as a prospective single arm multi-center trial, as the retrospective data suggest that there is no disadvantage in lymph node retrieval after RAG compared to LAG. Surgery is going to be performed according to the guidelines of the Japanese Research Society for the Study of Gastric Cancer (3rd edition). Japanese randomized controlled trials have proven effectiveness of adequate D2 lymphadenectomy in several randomized controlled trials. As number of dissected lymph nodes is a surrogate marker for adequate lymph node dissection, only patients with at least 25 lymph nodes removed (as obtained from pathology report) will be definitively included in the data assessment. Further lymph node stations No. #7, #8a, #9, #11p, #12a for subtotal gastrectomy according to the Japanese Guideline have to be dissected out of the surgical specimen and analyzed separately in the pathologic workup. All patients in the trial are going to be analyzed, as success rate of LN dissection in the N2-area is the primary endpoint. Surgery in the trial must be performed by a board certified surgeon who has taken part in a trial specific training course. Potential learning curve artefacts are negligible because the RAG is going to be performed by surgeons who are highly trained and experienced in robotic gastrectomy.

Participating surgeons should have experience as an operator of over 50 cases of open gastrectomy, over 50 laparoscopic gastrectomy, and over 15 cases of robotic gastrectomy. Furthermore, surgical quality will have to be enforced by intraoperative video documentation. Also, pictures of nodal dissection area after resection should be submitted to have a quality assurance.

Minimizing detection bias: Patients are going to regularly undergo standardized follow-up visits at 6, 12, 18, 24, 30, 36, 48, 60 months to be evaluated disease status with abdominopelvic CT. EGD will be done on 3, 12, 24, 36, 48 and 60 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: December 2021
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven adenocarcinoma of the stomach in patients that have not received any previous treatment for their cancer

• Tumours should be stage II or III according to the UICC 7th edition with no sign of distant metastasis and deemed resectable (R0) by the operating surgeon on preoperative staging by EGD, and CT of abdomen and pelvis

• Location of the tumor at the pylorus, antrum, angle, lower body and midbody to allow subtotal gastrectomy

• Age = 19 years

• Written informed consent

Exclusion Criteria:

• Performance status =3

• Patients not eligible for surgery (ASA >=4)

• History of another primary cancer, except curatively treated in situ cervical cancer, curatively resected non-melanoma skin cancer. The inclusion of patients with other types of cancer that were successfully treated and did not recur within the last 5 years prior to study enrolment have to be discussed with the principal investigator.

• Evidence of distant metastasis on clinical staging

• Primary tumour deemed unresectable by operating surgeon

• Inadequate organ function as below

• Bone marrow function defined as: (ANC =1.0x109/l, WBC (total) = 2.5x109/l, Platelet Count = 70x109/l, Haemoglobin = 8 g/dl (can be post-transfusion)

• Renal function with serum Creatinine =1.5 mg/dL) ? Liver function defined as (Total Bilirubin= 2.0x (ULN), ALT/AST =2.5x ULN) ? Coagulation profile: with PT (INR) =1.5, aPTT(sec) =1.5xULN

• Women of childbearing potential should have a negative pregnancy test within 7 days prior to commencing treatment, and must take adequate contraceptive precautions

• Simultaneous participation in another clinical trial.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Distal Gastrectomy with D2 LND
Robotic Distal Gastrectomy with D2 lymphadenectomy(#7, #8a, #9, #11p, #12a in Japanese Classification) for patient with stage II or III gastric cancer

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center of Korea	Goyang	Gyeonggi-do
Korea, Republic of	Aju University Hospital	Suwon	Gyeonggi-do

Sponsors (9)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Ajou University School of Medicine, Chung-Ang University Hospital, Keimyung University Dongsan Medical Center, Korea University, Samsung Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (14)

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Eom BW, Yoon HM, Ryu KW, Lee JH, Cho SJ, Lee JY, Kim CG, Choi IJ, Lee JS, Kook MC, Rhee JY, Park SR, Kim YW. Comparison of surgical performance and short-term clinical outcomes between laparoscopic and robotic surgery in distal gastric cancer. Eur J Surg — View Citation

Huscher CG, Mingoli A, Sgarzini G, Sansonetti A, Di Paola M, Recher A, Ponzano C. Laparoscopic versus open subtotal gastrectomy for distal gastric cancer: five-year results of a randomized prospective trial. Ann Surg. 2005 Feb;241(2):232-7. — View Citation

Kim YW, Baik YH, Yun YH, Nam BH, Kim DH, Choi IJ, Bae JM. Improved quality of life outcomes after laparoscopy-assisted distal gastrectomy for early gastric cancer: results of a prospective randomized clinical trial. Ann Surg. 2008 Nov;248(5):721-7. doi: 1 — View Citation

Kitano S, Shiraishi N, Uyama I, Sugihara K, Tanigawa N; Japanese Laparoscopic Surgery Study Group. A multicenter study on oncologic outcome of laparoscopic gastrectomy for early cancer in Japan. Ann Surg. 2007 Jan;245(1):68-72. — View Citation

Lakatos E, Lan KK. A comparison of sample size methods for the logrank statistic. Stat Med. 1992 Jan 30;11(2):179-91. — View Citation

Noshiro H, Shimizu S, Nagai E, Ohuchida K, Tanaka M. Laparoscopy-assisted distal gastrectomy for early gastric cancer: is it beneficial for patients of heavier weight? Ann Surg. 2003 Nov;238(5):680-5. — 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 E — View Citation

Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl — View Citation

Song J, Oh SJ, Kang WH, Hyung WJ, Choi SH, Noh SH. Robot-assisted gastrectomy with lymph node dissection for gastric cancer: lessons learned from an initial 100 consecutive procedures. Ann Surg. 2009 Jun;249(6):927-32. doi: 10.1097/01.sla.0000351688.64999 — View Citation

Uyama I, Kanaya S, Ishida Y, Inaba K, Suda K, Satoh S. Novel integrated robotic approach for suprapancreatic D2 nodal dissection for treating gastric cancer: technique and initial experience. World J Surg. 2012 Feb;36(2):331-7. doi: 10.1007/s00268-011-135 — View Citation

Woo Y, Hyung WJ, Pak KH, Inaba K, Obama K, Choi SH, Noh SH. Robotic gastrectomy as an oncologically sound alternative to laparoscopic resections for the treatment of early-stage gastric cancers. Arch Surg. 2011 Sep;146(9):1086-92. doi: 10.1001/archsurg.20 — View Citation

Yoon HM, Kim YW, Lee JH, Ryu KW, Eom BW, Park JY, Choi IJ, Kim CG, Lee JY, Cho SJ, Rho JY. Robot-assisted total gastrectomy is comparable with laparoscopically assisted total gastrectomy for early gastric cancer. Surg Endosc. 2012 May;26(5):1377-81. doi: — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of retrieved lymph nodes in the topographical N2 area	Number of retrieved lymph nodes in the topographical N2 area (#7, #8a, #9, #11p, #12a in Japanese Classification)	1 week	No
Secondary	Overall-survival	Overall-survival after five years of follow up	five years	No
Secondary	Recurrence-free survival	Three Year Recurrence-free survival	Three Year	No
Secondary	Incidence of local recurrence	Incidence of local recurrence	Five Year	No
Secondary	Early Complications	Early Complications( Abdominal wound complications , Fluid collection/intraabdominal abscess , Intraabdominal bleeding, Intraluminal bleeding, Anastomotic stenosis, Anastomotic leakage, Panceatic leakage, Pancreatitis, Atelectasis, Pneumonia, Urinary tract infection, Renal Dysfunction , Hepatic Dysfunction, Cardiac Disease ,Delayed gastric emptying : classified by Clavien-Dindo Classification(Definition and grading of complication) and be scored in accordance with the comprehensive complication index(http://assessurgery.com)	1 month	No
Secondary	Late Complications	Late Complications(Intestinal Obstruction(Ileus), Anastomotic Stenosis, Iron Deficiency Anemia, etc.): classified by Clavien-Dindo Classification(Definition and grading of complication) and be scored in accordance with the comprehensive complication index(http://assessurgery.com)	5 year	No
Secondary	Quality of life	Quality of life according to EQ-5	5 year	No

External Links

•   The official web site of National Cancer Center