Incidence of Pancreatic Fistula After Radical Gastrectomy
Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03391687
Collaborator
(none)
2,100
21
12
100
8.4
Study Details
Study Description
Brief Summary
This study is designed to investigate the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
2100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Investigation of Incidence of Pancreatic Fistula After Radical Gastrectomy in Gastric Cancer Patients
Actual Study Start Date
:
Dec 1, 2017
Anticipated Primary Completion Date
:
Nov 30, 2018
Anticipated Study Completion Date
:
Nov 30, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Amylase Test gastric cancer patients receiving radical gastrectomy |
Diagnostic Test: Amylase Test
body fluid amylase will be tested after radical gastrectomy in scheduled interval
|
Outcome Measures
Primary Outcome Measures
- Incidence of Pancreatic Fistula [in 30 days following gastrectomy]
the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients
Secondary Outcome Measures
- The Classification of Pancreatic Fistula [in 30 days following gastrectomy]
the percentage of different grades of pancreatic fistula, including Grade BL, Grade B and Grade C
- The mortality of Grade B and C Pancreatic Fistula [in 30 days following gastrectomy]
the percentage of patients died of Grade B or C pancreatic fistula
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Cancer Hospital | Beijing | Beijing | China | |
| 2 | Beijing Chao-Yang Hospital | Beijing | Beijing | China | |
| 3 | South West Hospital | Chongqing | Chongqing | China | |
| 4 | South West Hospital | Chongqing | Chongqing | China | |
| 5 | Fujian Cancer Hospital | Fuzhou | Fujian | China | |
| 6 | Fujian Medical University Union Hospital | Fuzhou | Fujian | China | |
| 7 | Guangdong General Hospital | Guangzhou | Guangdong | China | |
| 8 | The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China | |
| 9 | Henan Cancer Hospital | Zhengzhou | Henan | China | |
| 10 | Jiangsu Province Hospital | Nanjing | Jiangsu | China | |
| 11 | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China | |
| 12 | The Second Hospital of Jilin University | Changchun | Jilin | China | |
| 13 | Affiliated Hospital of Qinghai University | Xining | Qinghai | China | |
| 14 | Weifang People's Hospital | Weifang | Shandong | China | |
| 15 | ZhongShan hospital Fudan university | Shanghai | Shanghai | China | 200032 |
| 16 | Renji Hospital, Shanghai Jiaotong University | Shanghai | Shanghai | China | |
| 17 | Ruijing Hospital, Shanghai Jiaotong University | Shanghai | Shanghai | China | |
| 18 | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shanxi | China | |
| 19 | The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | China | |
| 20 | Hangzhou First People's Hospital | Hangzhou | Zhejiang | China | |
| 21 | Sir Run Run Shaw Hospital, Zhejiang University School of Medicince | Hangzhou | Zhejiang | China |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
Investigators
- Principal Investigator: Fenglin Liu, MD, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT03391687
Other Study ID Numbers:
- ZSGC-003
First Posted:
Jan 5, 2018
Last Update Posted:
Jan 5, 2018
Last Verified:
Jan 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shanghai Zhongshan Hospital
Additional relevant MeSH terms: