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
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Procedure: Distal Gastrectomy with D2 LND||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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)
- Overall-survival [ Time Frame: five years ]Overall-survival after five years of follow up
- Recurrence-free survival [ Time Frame: Three Year ]Three Year Recurrence-free survival
- Incidence of local recurrence [ Time Frame: Five Year ]Incidence of local recurrence
- 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)
- 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)
- Quality of life [ Time Frame: 5 year ]Quality of life according to EQ-5
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572050
|Contact: Young-Woo Kim, PhDfirstname.lastname@example.org|
|Contact: Hong Man Yoon, PhDemail@example.com|
|Korea, Republic of|
|National Cancer Center of Korea||Recruiting|
|Goyang, Gyeonggi-do, Korea, Republic of, 10408|
|Contact: Young-Woo Kim, Ph.D +821088691635 firstname.lastname@example.org|
|Contact: Youngsook Kim, BS +821077566208 email@example.com|
|Aju University Hospital||Recruiting|
|Suwon, Gyeonggi-do, Korea, Republic of, 443-380|
|Contact: Sang-Wook Han, Ph.D +8210-2911-9336 firstname.lastname@example.org|
|Contact: Hoon Hur, Ph.D +8210-2911-9336 email@example.com|
|Principal Investigator:||Young-Woo Kim, PhD||National Cancer Center of Korea|