Incidence of Pancreatic Fistula After Radical Gastrectomy
NCT ID: NCT03391687
Last Updated: 2018-01-05
Study Results
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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UNKNOWN
2100 participants
OBSERVATIONAL
2017-12-01
2018-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Amylase Test
gastric cancer patients receiving radical gastrectomy
Amylase Test
body fluid amylase will be tested after radical gastrectomy in scheduled interval
Interventions
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Amylase Test
body fluid amylase will be tested after radical gastrectomy in scheduled interval
Eligibility Criteria
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Inclusion Criteria
* preoperative curatively resectable tumor
Exclusion Criteria
* emergent surgery due to gastric cancer acute complications
* cancer of gastric remnant
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Fenglin Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
South West Hospital
Chongqing, Chongqing Municipality, China
South West Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangdong General Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Affiliated Hospital of Qinghai University
Xining, Qinghai, China
Weifang People's Hospital
Weifang, Shandong, China
ZhongShan hospital Fudan university
Shanghai, Shanghai Municipality, China
Renji Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Ruijing Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicince
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Ziyu Li, MD
Role: primary
Minzhe Li, MD
Role: primary
Yingxue Hao, MD
Role: primary
Yongliang Zhao, MD
Role: primary
Weidong Zang, MD
Role: primary
Chaohui Zheng, MD
Role: primary
Yong Li, MD
Role: primary
Wu Song, MD
Role: primary
Zhi Li, MD
Role: primary
Li Yang, MD
Role: primary
Zhengrong Li, MD
Role: primary
Jiaming Zhu, MD
Role: primary
Su Yan, MD
Role: primary
Jianjun Qu, MD
Role: primary
Gang Zhao, MD
Role: primary
Junjun Ma, MD
Role: primary
Zang Lu, MD
Role: backup
Lin Fan, MD
Role: primary
Wenbin Zhang, MD
Role: primary
Jian Zhang, MD
Role: primary
Linghua Zhu, MD
Role: primary
References
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Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
Yu HW, Jung DH, Son SY, Lee CM, Lee JH, Ahn SH, Park DJ, Kim HH. Risk factors of postoperative pancreatic fistula in curative gastric cancer surgery. J Gastric Cancer. 2013 Sep;13(3):179-84. doi: 10.5230/jgc.2013.13.3.179. Epub 2013 Sep 30.
Tanaka K, Miyashiro I, Yano M, Kishi K, Motoori M, Seki Y, Noura S, Ohue M, Yamada T, Ohigashi H, Ishikawa O. Accumulation of excess visceral fat is a risk factor for pancreatic fistula formation after total gastrectomy. Ann Surg Oncol. 2009 Jun;16(6):1520-5. doi: 10.1245/s10434-009-0391-y. Epub 2009 Mar 8.
Jiang X, Hiki N, Nunobe S, Kumagai K, Nohara K, Sano T, Yamaguchi T. Postoperative pancreatic fistula and the risk factors of laparoscopy-assisted distal gastrectomy for early gastric cancer. Ann Surg Oncol. 2012 Jan;19(1):115-21. doi: 10.1245/s10434-011-1893-y. Epub 2011 Jul 8.
Kobayashi D, Iwata N, Tanaka C, Kanda M, Yamada S, Nakayama G, Fujii T, Koike M, Fujiwara M, Kodera Y. Factors related to occurrence and aggravation of pancreatic fistula after radical gastrectomy for gastric cancer. J Surg Oncol. 2015 Sep;112(4):381-6. doi: 10.1002/jso.24001. Epub 2015 Aug 8.
Komatsu S, Ichikawa D, Kashimoto K, Kubota T, Okamoto K, Konishi H, Shiozaki A, Fujiwara H, Otsuji E. Risk factors to predict severe postoperative pancreatic fistula following gastrectomy for gastric cancer. World J Gastroenterol. 2013 Dec 14;19(46):8696-702. doi: 10.3748/wjg.v19.i46.8696.
Kung CH, Lindblad M, Nilsson M, Rouvelas I, Kumagai K, Lundell L, Tsai JA. Postoperative pancreatic fistula formation according to ISGPF criteria after D2 gastrectomy in Western patients. Gastric Cancer. 2014;17(3):571-7. doi: 10.1007/s10120-013-0307-1. Epub 2013 Oct 9.
Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
Other Identifiers
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ZSGC-003
Identifier Type: -
Identifier Source: org_study_id
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