Incidence of Pancreatic Fistula After Radical Gastrectomy

NCT ID: NCT03391687

Last Updated: 2018-01-05

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

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastric Cancer Pancreatic Fistula Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Amylase Test

gastric cancer patients receiving radical gastrectomy

Amylase Test

Intervention Type DIAGNOSTIC_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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

South West Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

South West Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

The Second Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Affiliated Hospital of Qinghai University

Xining, Qinghai, China

Site Status RECRUITING

Weifang People's Hospital

Weifang, Shandong, China

Site Status RECRUITING

ZhongShan hospital Fudan university

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Renji Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Ruijing Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Site Status RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status RECRUITING

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University School of Medicince

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhaoqing Tang, MD

Role: CONTACT

+86-13817125778

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

Fenglin Liu, MD

Role: primary

+86-13918765733

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.

Reference Type BACKGROUND
PMID: 28040257 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24156038 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19267237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21739317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26256914 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24379588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24105422 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16003309 (View on PubMed)

Other Identifiers

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ZSGC-003

Identifier Type: -

Identifier Source: org_study_id

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