NCT01978444

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
169

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

April 10, 2020

Status Verified

April 1, 2020

Enrollment Period

7 years

First QC Date

October 31, 2013

Last Update Submit

April 9, 2020

Conditions

Gastric Cancer

Keywords

D2 lymphadenectomyComplete Mesogastrium Excision

Outcome Measures

Primary Outcomes (1)

  • 3-year disease free survival

    3-years disease-free survival of the enrolled patients

    36 months

Secondary Outcomes (3)

  • Postoperative recovery course

    10 days

  • Morbidity and mortality

    30 days; 36 months

  • 3-year overall survival

    36 months

Other Outcomes (1)

  • Postoperative intraperitoneal free cancer cell (IFCC)

    within 1hour

Study Arms (2)

laparoscopic D2 lymphadenectomy plus CME

EXPERIMENTAL

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

Procedure: Laparoscopic D2 lymphadenectomy plus CME

laparoscopic D2 lymphadenectomy

ACTIVE COMPARATOR

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

Procedure: Laparoscopic D2 lymphadenectomy

Interventions

Laparoscopic D2 lymphadenectomy plus CMEPROCEDURE
laparoscopic D2 lymphadenectomy plus CME
Laparoscopic D2 lymphadenectomyPROCEDURE
laparoscopic D2 lymphadenectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Related Publications (14)

  • Sasako M, Saka M, Fukagawa T, Katai H, Sano T. Surgical treatment of advanced gastric cancer: Japanese perspective. Dig Surg. 2007;24(2):101-7. doi: 10.1159/000101896. Epub 2007 Apr 19.

    PMID: 17446702BACKGROUND

  • Wu CW, Hsiung CA, Lo SS, Hsieh MC, Chen JH, Li AF, Lui WY, Whang-Peng J. Nodal dissection for patients with gastric cancer: a randomised controlled trial. Lancet Oncol. 2006 Apr;7(4):309-15. doi: 10.1016/S1470-2045(06)70623-4.

    PMID: 16574546BACKGROUND

  • 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.

    PMID: 18523800BACKGROUND

  • 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.

    PMID: 15855922BACKGROUND

  • 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.

    PMID: 18931855BACKGROUND

  • 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.

    PMID: 23403142RESULT

  • 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.

    PMID: 27005289RESULT

  • 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.

    PMID: 26542081RESULT

  • 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.

    PMID: 26566136RESULT

  • 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.

    PMID: 30092843RESULT

  • Wu Y, He F, Liu L, Jiang W, Deng J, Zhang Y, Cao Z, Xu X, Gong J. The Use of CellCollector Assay to Detect Free Cancer Cells in the Peritoneal Cavity of Colorectal Cancer Patients: An Experimental Study. Cancer Med. 2024 Nov;13(21):e70378. doi: 10.1002/cam4.70378.

    PMID: 39503055DERIVED

  • Tu J, Shao S, Qin J. The number of mesogastria containing metastatic lymph nodes predicts gastric cancer prognosis. Surgery. 2024 Sep;176(3):739-747. doi: 10.1016/j.surg.2024.05.027. Epub 2024 Jun 15.

    PMID: 38879382DERIVED

  • Xie D, Shen J, Liu L, Cao B, Xiao A, Qin J, Wu J, Yan Q, Hu Y, Yang C, Cao Z, Hu J, Yin P, Gong J. Randomized clinical trial on D2 lymphadenectomy versus D2 lymphadenectomy plus complete mesogastric excision in patients undergoing gastrectomy for cancer (DCGC01 study). Br J Surg. 2024 May 3;111(5):znae106. doi: 10.1093/bjs/znae106.

    PMID: 38713611DERIVED

  • 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.

    PMID: 33763656DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Jianping Gong, M.D.,Ph.D.

    Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In this trial, patients and the follow-up staff are masked to the treatment allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of General Surgery

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 7, 2013

Study Start

September 1, 2014

Primary Completion

September 1, 2021

Study Completion

October 1, 2023

Last Updated

April 10, 2020

Record last verified: 2020-04

Locations

CN(1)