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

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ClinicalTrials.gov Identifier: NCT02572050
Recruitment Status : Recruiting
First Posted : October 8, 2015
Last Update Posted : April 20, 2016
Sponsor:
Collaborators:
Keimyung University Dongsan Medical Center
Seoul National University Hospital
Seoul National University Bundang Hospital
Samsung Medical Center
Severance Hospital
Ajou University School of Medicine
Korea University
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Information provided by (Responsible Party):
Young-Woo Kim, National Cancer Center, Korea

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: Distal Gastrectomy with D2 LND Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of a Robotic Distal Gastrectomy on Non-inferiority of N2 Area Nodal Dissection for Clinical Stage II or III Gastric Cancer
Study Start Date : October 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Robotic Distal Gastrectomy with D2 LND
Robotic Distal Gastrectomy (RDG) with D2 LND for patient with stage II or III gastric cancer The primary efficacy endpoint of number of dissected lymph nodes in the N2 area (which is #7, #8a, #9, #11p and #12a according to the JRSSGC) after oncologic resection for clinical stage II or III gastric adenocarcinoma.assessment.
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
Other Name: Robotic Distal Gastrectomy with D2 LND




Primary Outcome Measures :
  1. Number of retrieved lymph nodes in the topographical N2 area [ Time Frame: 1 week ]
    Number of retrieved lymph nodes in the topographical N2 area (#7, #8a, #9, #11p, #12a in Japanese Classification)


Secondary Outcome Measures :
  1. Overall-survival [ Time Frame: five years ]
    Overall-survival after five years of follow up

  2. Recurrence-free survival [ Time Frame: Three Year ]
    Three Year Recurrence-free survival

  3. Incidence of local recurrence [ Time Frame: Five Year ]
    Incidence of local recurrence

  4. Early Complications [ Time Frame: 1 month ]
    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)

  5. Late Complications [ Time Frame: 5 year ]
    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)

  6. Quality of life [ Time Frame: 5 year ]
    Quality of life according to EQ-5



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) ③ Liver function defined as (Total Bilirubin≥ 2.0x (ULN), ALT/AST ≥2.5x ULN) ④ 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.

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): NCT02572050


Contacts
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Contact: Young-Woo Kim, PhD +821088691635 gskim@ncc.re.kr
Contact: Hong Man Yoon, PhD +821063568426 red10000@ncc.re.kr

Locations
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Korea, Republic of
National Cancer Center of Korea Recruiting
Goyang, Gyeonggi-do, Korea, Republic of, 10408
Contact: Young-Woo Kim, Ph.D    +821088691635    gskim@ncc.re.kr   
Contact: Youngsook Kim, BS    +821077566208    trueclear@ncc.re.kr   
Aju University Hospital Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 443-380
Contact: Sang-Wook Han, Ph.D    +8210-2911-9336    hansu@ajou.ac.kr   
Contact: Hoon Hur, Ph.D    +8210-2911-9336    hhcmc75@naver.com   
Sponsors and Collaborators
National Cancer Center, Korea
Keimyung University Dongsan Medical Center
Seoul National University Hospital
Seoul National University Bundang Hospital
Samsung Medical Center
Severance Hospital
Ajou University School of Medicine
Korea University
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Investigators
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Principal Investigator: Young-Woo Kim, PhD National Cancer Center of Korea
Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: Young-Woo Kim, Professor, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02572050    
Other Study ID Numbers: NCC2015-0191
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
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