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Trial record 1 of 1 for:    NCT01978444
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Study on Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision(D2+CME)for Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01978444
Recruitment Status : Active, not recruiting
First Posted : November 7, 2013
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
Jianping Gong, Huazhong University of Science and Technology

Brief Summary:

Radical gastrectomy for gastric cancer with D2 lymph node dissection has been widely applied in advanced gastric cancer. However,for most patients,tumor local-regional recurrence has been proven unavoidable.

Recently, many clinical studies have proved that some cancer cells and cancer nodes exist in the mesogastrium which can be hardly removed by conventional radical gastrectomy with D2 lymphadenectomy. It is suggested that Complete mesogastrium excision (CME) is imperative and should be added to D2 lymphadenectomy in order to reduce the risk of local recurrence.

Thus, the comparison of short-term and long-term outcome between laparoscopic D2 lymphadenectomy plus complete mesogastrium excision and conventional laparoscopic D2 lymphadenectomy for locally advanced gastric cancer based on a well designed randomized controlled trial is needed.


Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: Laparoscopic D2 lymphadenectomy plus CME Procedure: Laparoscopic D2 lymphadenectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: In this trial, patients and the follow-up staff are masked to the treatment allocation.
Primary Purpose: Prevention
Official Title: Prospective Randomized Controlled Trial of Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision(D2+CME)vs. Laparoscopic D2 Lymphadenectomy for Advanced Gastric Cancer
Actual Study Start Date : September 2014
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: laparoscopic D2 lymphadenectomy plus CME
Laparoscopic D2 lymphadenectomy plus CME will be performed for the treatment of patients assigned to this group.
Procedure: Laparoscopic D2 lymphadenectomy plus CME
Active Comparator: laparoscopic D2 lymphadenectomy
Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Procedure: Laparoscopic D2 lymphadenectomy



Primary Outcome Measures :
  1. 3-year disease free survival [ Time Frame: 36 months ]
    3-years disease-free survival of the enrolled patients


Secondary Outcome Measures :
  1. Postoperative recovery course [ Time Frame: 10 days ]
    Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay. The amount of abdominal drainage and blood transfusion are also recorded.

  2. Morbidity and mortality [ Time Frame: 30 days; 36 months ]

    The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.

    • 3-year overall survival rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    • 3-year recurrence pattern [ Time Frame: 36 months ] [ Designated as safety issue: No ]

    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.


  3. 3-year overall survival [ Time Frame: 36 months ]
    3-years overall survival of the enrolled patients


Other Outcome Measures:
  1. Postoperative intraperitoneal free cancer cell (IFCC) [ Time Frame: within 1hour ]
    Positive rate of cancer cells from intraperitoneal wash samples after gastrectomy



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Age from over 18 to under 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition Expected curative resection through gastrectomy with D2 lymphadenectomy Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) score class I, II, or III Informed consent obtained from patients or their appointed agent

Exclusion Criteria:

Patients treated with neoadjuvant chemotherapy or radiation therapy; Patients with history of upper abdominal surgery; History with other severe comorbidities and cannot tolerate laparoscopic surgery, such as severe heart and lung diseases, heart function below clinical stage 2, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc; Patients suffering from malignant diseases before the study or with other gastric malignant diseases, such as lymphoma and stromal tumors, etc.; Pregnant woman and woman during lactation; Patients with mental sickness; The patient compliance is bad or the researcher expect there will not be good patient compliance;


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): NCT01978444


Locations
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China, Hubei
Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Principal Investigator: Jianping Gong, M.D.,Ph.D. Huazhong University of Science and Technology
Publications of Results:
Other Publications:
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Responsible Party: Jianping Gong, Director of Department of General Surgery, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01978444    
Other Study ID Numbers: TJ-20131101
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Keywords provided by Jianping Gong, Huazhong University of Science and Technology:
D2 lymphadenectomy
Complete Mesogastrium Excision
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