Incidence of Pancreatic Fistula After Radical Gastrectomy

Gastric Cancer Clinical Trial

Official title:

Investigation of Incidence of Pancreatic Fistula After Radical Gastrectomy in Gastric Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03391687
• Other study ID #: ZSGC-003
• Status: Recruiting
• Phase: N/A
• First received: December 15, 2017
• Last updated: January 1, 2018
• Start date: December 1, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: January 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Zhaoqing Tang, MD
• Phone: +86-13817125778
• Email: tang.zhaoqing[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is designed to investigate the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients.

Description:

Pancreatic fistula, which can lead to fatal end, is one of the most serious complications after radical gastrectomy. It is usually treated as a key factor to evaluate the quality of gastrectomy. The incidence of pancreatic fistula is far different between different areas, knowing the prevalence of pancreatic fistula and risk factors can help us to prevent pancreatic fistula and improve the short time outcome of gastric cancer surgery treatment. So, we designed this perspective, multi-center study to investigate the incidence of pancreatic fistula and its outcome in China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pathological confirmed stomach adenocarcinoma

• preoperative curatively resectable tumor

Exclusion Criteria:

• pancreas resection

• emergent surgery due to gastric cancer acute complications

• cancer of gastric remnant

Related Conditions & MeSH terms

• Complication
• Fistula
• Gastric Cancer
• Pancreatic Fistula
• Stomach Neoplasms

Intervention

Diagnostic Test:
• Amylase Test
body fluid amylase will be tested after radical gastrectomy in scheduled interval

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Chao-Yang Hospital	Beijing	Beijing
China	The Second Hospital of Jilin University	Changchun	Jilin
China	South West Hospital	Chongqing	Chongqing
China	South West Hospital	Chongqing	Chongqing
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	Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicince	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Renji Hospital, Shanghai Jiaotong University	Shanghai	Shanghai
China	Ruijing Hospital, Shanghai Jiaotong University	Shanghai	Shanghai
China	ZhongShan hospital Fudan university	Shanghai	Shanghai
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Weifang People's Hospital	Weifang	Shandong
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Affiliated Hospital of Qinghai University	Xining	Qinghai
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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. Review. — View Citation

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 CR, 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Pancreatic Fistula	the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients	in 30 days following gastrectomy
Secondary	The Classification of Pancreatic Fistula	the percentage of different grades of pancreatic fistula, including Grade BL, Grade B and Grade C	in 30 days following gastrectomy
Secondary	The mortality of Grade B and C Pancreatic Fistula	the percentage of patients died of Grade B or C pancreatic fistula	in 30 days following gastrectomy