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

Gastric Cancer Clinical Trial

Official title:

Prospective Randomized Controlled Trial of Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision（D2+CME）vs. Laparoscopic D2 Lymphadenectomy for Advanced Gastric Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01978444
• Other study ID #: TJ-20131101
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: October 2023

Study information

• Verified date: April 2020
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 169
• Est. completion date: October 2023
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic D2 lymphadenectomy plus CME

• Laparoscopic D2 lymphadenectomy

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (10)

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. Review. — View 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. — View 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. — View Citation

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. Epub 2007 Apr 19. Review. — View 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 — View Citation

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. — View 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. — View 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 — View 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. — View 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. Epub 2016 Mar 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative intraperitoneal free cancer cell (IFCC)	Positive rate of cancer cells from intraperitoneal wash samples after gastrectomy	within 1hour
Primary	3-year disease free survival	3-years disease-free survival of the enrolled patients	36 months
Secondary	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.	10 days
Secondary	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.	30 days; 36 months
Secondary	3-year overall survival	3-years overall survival of the enrolled patients	36 months