Incidence of Pancreatic Fistula After Radical Gastrectomy
Investigation of Incidence of Pancreatic Fistula After Radical Gastrectomy in Gastric Cancer Patients
1 other identifier
observational
2,100
1 country
21
Brief Summary
This study is designed to investigate the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2017
Shorter than P25 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 15, 2017
CompletedFirst Posted
Study publicly available on registry
January 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedJanuary 5, 2018
January 1, 2018
12 months
December 15, 2017
January 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Pancreatic Fistula
the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients
in 30 days following gastrectomy
Secondary Outcomes (2)
The Classification of Pancreatic Fistula
in 30 days following gastrectomy
The mortality of Grade B and C Pancreatic Fistula
in 30 days following gastrectomy
Study Arms (1)
Amylase Test
gastric cancer patients receiving radical gastrectomy
Interventions
body fluid amylase will be tested after radical gastrectomy in scheduled interval
Eligibility Criteria
stomach adenocarcinoma patients who recieved radical gastrectomy
You may qualify if:
- pathological confirmed stomach adenocarcinoma
- preoperative curatively resectable tumor
You may not qualify if:
- pancreas resection
- emergent surgery due to gastric cancer acute complications
- cancer of gastric remnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
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, 200032, 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
Related Publications (8)
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.
PMID: 28040257BACKGROUNDYu 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.
PMID: 24156038BACKGROUNDTanaka 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.
PMID: 19267237BACKGROUNDJiang 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.
PMID: 21739317BACKGROUNDKobayashi 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.
PMID: 26256914BACKGROUNDKomatsu 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.
PMID: 24379588BACKGROUNDKung 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.
PMID: 24105422BACKGROUNDBassi 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.
PMID: 16003309BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fenglin Liu, MD
Fudan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2017
First Posted
January 5, 2018
Study Start
December 1, 2017
Primary Completion
November 30, 2018
Study Completion
November 30, 2018
Last Updated
January 5, 2018
Record last verified: 2018-01