Comparison of Short Term Outcomes Between Totally Laparoscopic and Laparoscopy-Assisted Distal Gastrectomy With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Locally Advanced Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02365896
• Other study ID #: TLDG vs. LADG
• Status: Not yet recruiting
• Phase: N/A
• First received: January 23, 2015
• Last updated: April 24, 2015
• Start date: June 2015

Study information

• Verified date: January 2015
• Source: Fujian Cancer Hospital
• Contact: Weidong Zang, Associate chief physician
• Phone: 13600815361
• Email: fjzangwd[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The diagnosis of gastric cancer was confirmed by pathological examination

• Preoperative staging as cT2-4aN0-3M0 according to AJCC-7th

• No accompany with another cancer

• ECOG 0-1

• ASA I-III

• Agreement

Exclusion Criteria:

• Pregnant or suckling period

• Patients with a history of preoperative chemoradiotherapy

• Patients with unable to finish D2 lymphadenectomy or R0 resection

• Laparoscopic surgery contraindications

• Serious organ disfunction

• Accompany with serious mental disease

• Continuous treatment with steroid in 1 month

• Disagreement

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced Gastric Cancer
• Stomach Neoplasms
• Total Laparoscopic Distal Gastrectomy

Intervention

Procedure:
• TLDG or LADG

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

References & Publications (8)

Han G, Park JY, Kim YJ. Comparison of short-term postoperative outcomes in totally laparoscopic distal gastrectomy versus laparoscopy-assisted distal gastrectomy. J Gastric Cancer. 2014 Jun;14(2):105-10. doi: 10.5230/jgc.2014.14.2.105. Epub 2014 Jun 30. Erratum in: J Gastric Cancer. 2014 Dec;14(4):284. — View Citation

Ikeda O, Sakaguchi Y, Aoki Y, Harimoto N, Taomoto J, Masuda T, Ohga T, Adachi E, Toh Y, Okamura T, Baba H. Advantages of totally laparoscopic distal gastrectomy over laparoscopically assisted distal gastrectomy for gastric cancer. Surg Endosc. 2009 Oct;23(10):2374-9. doi: 10.1007/s00464-009-0360-3. Epub 2009 Mar 5. — View Citation

Kim BS, Yook JH, Choi YB, Kim KC, Kim MG, Kim TH, Kawada H, Kim BS. Comparison of early outcomes of intracorporeal and extracorporeal gastroduodenostomy after laparoscopic distal gastrectomy for gastric cancer. J Laparoendosc Adv Surg Tech A. 2011 Jun;21(5):387-91. doi: 10.1089/lap.2010.0515. Epub 2011 May 11. — View Citation

Kim MG, Kim KC, Kim BS, Kim TH, Kim HS, Yook JH, Kim BS. A totally laparoscopic distal gastrectomy can be an effective way of performing laparoscopic gastrectomy in obese patients (body mass index=30). World J Surg. 2011 Jun;35(6):1327-32. doi: 10.1007/s00268-011-1034-6. — View Citation

Lee J, Kim D, Kim W. Comparison of laparoscopy-assisted and totally laparoscopic Billroth-II distal gastrectomy for gastric cancer. J Korean Surg Soc. 2012 Mar;82(3):135-42. doi: 10.4174/jkss.2012.82.3.135. Epub 2012 Feb 27. — View Citation

Oki E, Sakaguchi Y, Ohgaki K, Saeki H, Chinen Y, Minami K, Sakamoto Y, Toh Y, Kusumoto T, Maehara Y. Feasibility of delta-shaped anastomoses in totally laparoscopic distal gastrectomy. Eur Surg Res. 2011;47(4):205-10. doi: 10.1159/000332850. Epub 2011 Oct 13. — View Citation

Song KY, Park CH, Kang HC, Kim JJ, Park SM, Jun KH, Chin HM, Hur H. Is totally laparoscopic gastrectomy less invasive than laparoscopy-assisted gastrectomy?: prospective, multicenter study. J Gastrointest Surg. 2008 Jun;12(6):1015-21. doi: 10.1007/s11605-008-0484-0. Epub 2008 Feb 7. — View Citation

Woo J, Lee JH, Shim KN, Jung HK, Lee HM, Lee HK. Does the Difference of Invasiveness between Totally Laparoscopic Distal Gastrectomy and Laparoscopy-Assisted Distal Gastrectomy Lead to a Difference in Early Surgical Outcomes? A Prospective Randomized Trial. Ann Surg Oncol. 2015;22(6):1836-43. doi: 10.1245/s10434-014-4229-x. Epub 2014 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative early anastomotic morbidity		30 days	Yes
Secondary	Flatus time		7 days	Yes
Secondary	Quality of life	estimated with EORTC QLQ-C30V3?EORTC QLQ-STO22	30 days	Yes
Secondary	Postoperative hospital stay		30 days	Yes
Secondary	Pain score		10 days	Yes
Secondary	Postoperative inflammation response	using C-reactive protein?IL-6?WBC and so on postoperative 1,3,5,7 days	10 days	Yes
Secondary	Nutrition	NRS-2002 and PG-SGA in 30 days	30 days	Yes