Clinical trial · Interventional
Study on Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision（D2+CME）for Advanced Gastric Cancer
Prospective Randomized Controlled Trial of Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision（D2+CME）vs. Laparoscopic D2 Lymphadenectomy for Advanced Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic D2 lymphadenectomy | Procedure | — | UNRESOLVED |
| Laparoscopic D2 lymphadenectomy plus CME | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- laparoscopic D2 lymphadenectomy plus CME
- description
- Laparoscopic D2 lymphadenectomy plus CME will be performed for the treatment of patients assigned to this group.
- interventionNames
- Procedure: Laparoscopic D2 lymphadenectomy plus CME
- type
- ACTIVE_COMPARATOR
- label
- laparoscopic D2 lymphadenectomy
- description
- Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.
- interventionNames
- Procedure: Laparoscopic D2 lymphadenectomy
Primary outcomes (1)
- measure
- 3-year disease free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (14)
- BACKGROUNDSasako 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 17446702
- BACKGROUNDWu 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 16574546
- BACKGROUNDMenges 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 18523800
- BACKGROUNDNakamura 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 15855922
- BACKGROUNDNagatomo 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 18931855
- RESULTXie 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 23403142
- RESULTXie 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.