Postoperative Morbidity and Mortality After Gastrectomy for Gastric Cancer: Prospective Cohort Study

NCT ID: NCT01919242

Last Updated: 2019-01-11

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

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2023-09-30

Brief Summary

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Gastric cancer is still one of the main health care issue and gastrectomy with lymph node dissection is the only chance to be cure. Even though the development and standardization of gastric cancer surgery, the morbidity of gastric cancer surgery was reported around 20% with less than 1% of mortality in East. In contrast, around 40% of morbidity and 10% of mortality was reported in West. There has been several indexes which can define the complications after surgery, but adapting it into clinical practice is sometimes difficult due to the heterogeneous opinion between surgeons. Thus for clear defining the complications after surgery, consensus between many surgeons and prospective cohort study is necessary. The purpose of this study is collecting the complications data after gastric cancer surgery and defining it with every week meeting by at least 6 or more surgeons' discussion.

Detailed Description

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Conditions

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Patients Who Underwent Gastrectomy With Lymph Node Dissection for Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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with morbidity

patients who suffered from any type of morbidity after surgery

gastrectomy

Intervention Type PROCEDURE

gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer

without morbidity

patients who did not suffer from any type of morbidity after surgery

gastrectomy

Intervention Type PROCEDURE

gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer

Interventions

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gastrectomy

gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients who had histologically confirmed gastric cancer and are going to underwent gastrectomy
* age over 20 years with agree to the study

Exclusion Criteria

* withdrawal of their agreement
* vulnerable subjects (ex. pregnancy, disabled to decide by him or herself, cannot understand the study such as mental retardation or foreigner)
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Woo Jin Hyung, MD

Role: CONTACT

82-2-2228-2100

Facility Contacts

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Woo Jin Hyung, MD

Role: primary

82-2-2228-2100

References

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Hartgrink HH, van de Velde CJ, Putter H, Bonenkamp JJ, Klein Kranenbarg E, Songun I, Welvaart K, van Krieken JH, Meijer S, Plukker JT, van Elk PJ, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H, Sasako M. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial. J Clin Oncol. 2004 Jun 1;22(11):2069-77. doi: 10.1200/JCO.2004.08.026. Epub 2004 Apr 13.

Reference Type BACKGROUND
PMID: 15082726 (View on PubMed)

Cuschieri A, Weeden S, Fielding J, Bancewicz J, Craven J, Joypaul V, Sydes M, Fayers P. Patient survival after D1 and D2 resections for gastric cancer: long-term results of the MRC randomized surgical trial. Surgical Co-operative Group. Br J Cancer. 1999 Mar;79(9-10):1522-30. doi: 10.1038/sj.bjc.6690243.

Reference Type BACKGROUND
PMID: 10188901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16574546 (View on PubMed)

Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62. doi: 10.1056/NEJMoa0707035.

Reference Type BACKGROUND
PMID: 18669424 (View on PubMed)

Bonenkamp JJ, Songun I, Hermans J, Sasako M, Welvaart K, Plukker JT, van Elk P, Obertop H, Gouma DJ, Taat CW, et al. Randomised comparison of morbidity after D1 and D2 dissection for gastric cancer in 996 Dutch patients. Lancet. 1995 Mar 25;345(8952):745-8. doi: 10.1016/s0140-6736(95)90637-1.

Reference Type BACKGROUND
PMID: 7891484 (View on PubMed)

Cuschieri A, Fayers P, Fielding J, Craven J, Bancewicz J, Joypaul V, Cook P. Postoperative morbidity and mortality after D1 and D2 resections for gastric cancer: preliminary results of the MRC randomised controlled surgical trial. The Surgical Cooperative Group. Lancet. 1996 Apr 13;347(9007):995-9. doi: 10.1016/s0140-6736(96)90144-0.

Reference Type BACKGROUND
PMID: 8606613 (View on PubMed)

Degiuli M, Sasako M, Ponti A, Soldati T, Danese F, Calvo F. Morbidity and mortality after D2 gastrectomy for gastric cancer: results of the Italian Gastric Cancer Study Group prospective multicenter surgical study. J Clin Oncol. 1998 Apr;16(4):1490-3. doi: 10.1200/JCO.1998.16.4.1490.

Reference Type BACKGROUND
PMID: 9552056 (View on PubMed)

Kodera Y, Sasako M, Yamamoto S, Sano T, Nashimoto A, Kurita A; Gastric Cancer Surgery Study Group of Japan Clinical Oncology Group. Identification of risk factors for the development of complications following extended and superextended lymphadenectomies for gastric cancer. Br J Surg. 2005 Sep;92(9):1103-9. doi: 10.1002/bjs.4979.

Reference Type BACKGROUND
PMID: 16106493 (View on PubMed)

Park DJ, Lee HJ, Kim HH, Yang HK, Lee KU, Choe KJ. Predictors of operative morbidity and mortality in gastric cancer surgery. Br J Surg. 2005 Sep;92(9):1099-102. doi: 10.1002/bjs.4952.

Reference Type BACKGROUND
PMID: 15931657 (View on PubMed)

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

Reference Type BACKGROUND
PMID: 19638912 (View on PubMed)

Strasberg SM, Linehan DC, Hawkins WG. The accordion severity grading system of surgical complications. Ann Surg. 2009 Aug;250(2):177-86. doi: 10.1097/SLA.0b013e3181afde41.

Reference Type BACKGROUND
PMID: 19638919 (View on PubMed)

Other Identifiers

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4-2012-0800

Identifier Type: -

Identifier Source: org_study_id

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