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Study on Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision(D2+CME)for Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic D2 lymphadenectomy plus CME
Laparoscopic D2 lymphadenectomy
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Cancer focused on measuring D2 lymphadenectomy, Complete Mesogastrium Excision

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

laparoscopic D2 lymphadenectomy plus CME

laparoscopic D2 lymphadenectomy

Arm Description

Laparoscopic D2 lymphadenectomy plus CME will be performed for the treatment of patients assigned to this group.

Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.

Outcomes

Primary Outcome Measures

3-year disease free survival
3-years disease-free survival of the enrolled patients

Secondary Outcome Measures

Postoperative recovery course
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.
Morbidity and mortality
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-year overall survival
3-years overall survival of the enrolled patients

Full Information

First Posted
October 31, 2013
Last Updated
April 9, 2020
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01978444
Brief Title
Study on Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision(D2+CME)for Advanced Gastric Cancer
Official Title
Prospective Randomized Controlled Trial of Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision(D2+CME)vs. Laparoscopic D2 Lymphadenectomy for Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
D2 lymphadenectomy, Complete Mesogastrium Excision

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
In this trial, patients and the follow-up staff are masked to the treatment allocation.
Allocation
Randomized
Enrollment
169 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic D2 lymphadenectomy plus CME
Arm Type
Experimental
Arm Description
Laparoscopic D2 lymphadenectomy plus CME will be performed for the treatment of patients assigned to this group.
Arm Title
laparoscopic D2 lymphadenectomy
Arm Type
Active Comparator
Arm Description
Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic D2 lymphadenectomy plus CME
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic D2 lymphadenectomy
Primary Outcome Measure Information:
Title
3-year disease free survival
Description
3-years disease-free survival of the enrolled patients
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Postoperative recovery course
Description
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.
Time Frame
10 days
Title
Morbidity and mortality
Description
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.
Time Frame
30 days; 36 months
Title
3-year overall survival
Description
3-years overall survival of the enrolled patients
Time Frame
36 months
Other Pre-specified Outcome Measures:
Title
Postoperative intraperitoneal free cancer cell (IFCC)
Description
Positive rate of cancer cells from intraperitoneal wash samples after gastrectomy
Time Frame
within 1hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianping Gong, M.D.,Ph.D.
Organizational Affiliation
Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
17446702
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
18523800
Citation
Menges M, Hoehler T. Current strategies in systemic treatment of gastric cancer and cancer of the gastroesophageal junction. J Cancer Res Clin Oncol. 2009 Jan;135(1):29-38. doi: 10.1007/s00432-008-0425-z. Epub 2008 Jun 4.
Results Reference
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PubMed Identifier
15855922
Citation
Nakamura K, Ozaki N, Yamada T, Hata T, Sugimoto S, Hikino H, Kanazawa A, Tokuka A, Nagaoka S. Evaluation of prognostic significance in extracapsular spread of lymph node metastasis in patients with gastric cancer. Surgery. 2005 May;137(5):511-7. doi: 10.1016/j.surg.2005.01.007.
Results Reference
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PubMed Identifier
18931855
Citation
Nagatomo A, Abe N, Takeuchi H, Yanagida O, Masaki T, Mori T, Sugiyama M, Ohkura Y, Fujioka Y, Atomi Y. Microscopic cancer cell spread in gastric cancer: whole-section analysis of mesogastrium. Langenbecks Arch Surg. 2009 Jul;394(4):655-60. doi: 10.1007/s00423-008-0427-y. Epub 2008 Oct 18.
Results Reference
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PubMed Identifier
23403142
Citation
Xie D, Osaiweran H, Liu L, Wang X, Yu C, Tong Y, Hu J, Gong J. Mesogastrium: a fifth route of metastasis in gastric cancer? Med Hypotheses. 2013 Apr;80(4):498-500. doi: 10.1016/j.mehy.2012.12.020. Epub 2013 Feb 10.
Results Reference
result
PubMed Identifier
27005289
Citation
Xie D, Yu C, Liu L, Osaiweran H, Gao C, Hu J, Gong J. Short-term outcomes of laparoscopic D2 lymphadenectomy with complete mesogastrium excision for advanced gastric cancer. Surg Endosc. 2016 Nov;30(11):5138-5139. doi: 10.1007/s00464-016-4847-4. Epub 2016 Mar 22.
Results Reference
result
PubMed Identifier
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Citation
Xie D, Gao C, Lu A, Liu L, Yu C, Hu J, Gong J. Proximal segmentation of the dorsal mesogastrium reveals new anatomical implications for laparoscopic surgery. Sci Rep. 2015 Nov 6;5:16287. doi: 10.1038/srep16287.
Results Reference
result
PubMed Identifier
26566136
Citation
Xie D, Liu L, Osaiweran H, Yu C, Sheng F, Gao C, Hu J, Gong J. Detection and Characterization of Metastatic Cancer Cells in the Mesogastrium of Gastric Cancer Patients. PLoS One. 2015 Nov 13;10(11):e0142970. doi: 10.1371/journal.pone.0142970. eCollection 2015. Erratum In: PLoS One. 2016;11(1):e0148681.
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PubMed Identifier
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Citation
Shen J, Cao B, Wang Y, Xiao A, Qin J, Wu J, Yan Q, Hu Y, Yang C, Cao Z, Hu J, Yin P, Xie D, Gong J. Prospective randomized controlled trial to compare laparoscopic distal gastrectomy (D2 lymphadenectomy plus complete mesogastrium excision, D2 + CME) with conventional D2 lymphadenectomy for locally advanced gastric adenocarcinoma: study protocol for a randomized controlled trial. Trials. 2018 Aug 9;19(1):432. doi: 10.1186/s13063-018-2790-5.
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PubMed Identifier
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Citation
Xie D, Shen J, Liu L, Cao B, Wang Y, Qin J, Wu J, Yan Q, Hu Y, Yang C, Cao Z, Hu J, Yin P, Gong J. Complete mesogastric excision for locally advanced gastric cancer: short-term outcomes of a randomized clinical trial. Cell Rep Med. 2021 Mar 16;2(3):100217. doi: 10.1016/j.xcrm.2021.100217. eCollection 2021 Mar 16.
Results Reference
derived

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Study on Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision(D2+CME)for Advanced Gastric Cancer

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