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

NCT ID: NCT02365896

Last Updated: 2015-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Total Laparoscopic Distal Gastrectomy Locally Advanced Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TLDG or LADG

To complete the distal gastrectomy with Billroth-II reconstruction and D2 lymphadenectomy for locally advanced gastric cancer with TLDG or LADG

Group Type OTHER

TLDG or LADG

Intervention Type PROCEDURE

Interventions

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TLDG or LADG

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Weidong Zang, Associate chief physician

Role: CONTACT

13600815361

Wenhao Teng, Doctor

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 19263143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25061537 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22004901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21561328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21424875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22403746 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25395149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18256884 (View on PubMed)

Other Identifiers

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TLDG vs. LADG

Identifier Type: -

Identifier Source: org_study_id

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