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Gastric CancerNCT03391687

Incidence of Pancreatic Fistula After Radical Gastrectomy

An observational study of Gastric Cancer and Pancreatic Fistula, run by Shanghai Zhongshan Hospital at 21 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Any age
Conditions the study is for
Gastric Cancer, Pancreatic Fistula, Complication
What is being tested?
Amylase Test
How many people
2,100 participants
Where
21 sitesChina
Study dates
1 Dec 2017to 30 Nov 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: stomach adenocarcinoma patients who recieved radical gastrectomy

Who may be able to join

  • pathological confirmed stomach adenocarcinoma
  • preoperative curatively resectable tumor

Who cannot join

  • pancreas resection
  • emergent surgery due to gastric cancer acute complications
  • cancer of gastric remnant

Trial locations and contacts

21 sites in 1 country.

Zhaoqing Tang, MD contact

+86-13817125778

tang.zhaoqing@zs-hospital.sh.cn

21 sites in 1 country

China21 sites, 21 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Ziyu Li, MD

    Ziyu Li, MD

    Recruiting

  • Beijing Chao-Yang Hospital

    Beijing, Beijing Municipality

    Minzhe Li, MD

    Minzhe Li, MD

    Recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin

    Jiaming Zhu, MD

    Jiaming Zhu

    Recruiting

  • South West Hospital

    Chongqing, Chongqing Municipality

    Yingxue Hao, MD

    Yingxue Hao, MD

    Recruiting

  • South West Hospital

    Chongqing, Chongqing Municipality

    Yongliang Zhao, MD

    Yongliang Zhao, MD

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Weidong Zang, MD

    Weidong Zang, MD

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

    Chaohui Zheng, MD

    Chaohui Zheng, MD

    Recruiting

  • Guangdong General Hospital

    Guangzhou, Guangdong

    Yong Li, MD

    Yong Li, MD

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Wu Song, MD

    Wu Song, MD

    Recruiting

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang

    Jian Zhang, MD

    Jian Zhang, MD

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicince

    Hangzhou, Zhejiang

    Linghua Zhu, MD

    Linghua Zhu, MD

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Zhengrong Li, MD

    Zhengrong Li, MD

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

    Li Yang, MD

    Li Yang, MD

    Recruiting

  • ZhongShan hospital Fudan university

    Shanghai, Shanghai Municipality, 200032

    Fenglin Liu, MD, +86-13918765733, liu.fenglin@zs-hospital.sh.cn

    Fenglin Liu, MD

    Recruiting

  • Renji Hospital, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality

    Gang Zhao, MD

    Gang Zhao, MD

    Recruiting

  • Ruijing Hospital, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality

    Junjun Ma, MD

    Zang Lu, MD

    Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

    Wenbin Zhang, MD

    Wenbin Zhang, MD

    Recruiting

  • Weifang People's Hospital

    Weifang, Shandong

    Jianjun Qu, MD

    Jianjun Qu, MD

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

    Lin Fan, MD

    Lin Fan, MD

    Recruiting

  • Affiliated Hospital of Qinghai University

    Xining, Qinghai

    Su Yan, MD

    Su Yan, MD

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Zhi Li, MD

    Zhi Li, MD

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
Amylase Test
Keywords
Gastric Cancer, Pancreatic Fistula, Gastrectomy
Medical subject headings
Stomach Neoplasms, Pancreatic Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amylase TestDiagnostic test

    body fluid amylase will be tested after radical gastrectomy in scheduled interval

Study groups in NCT03391687
Study groupRoleWhat they receive
Amylase Testgastric cancer patients receiving radical gastrectomy
Receives: Diagnostic Test: Amylase Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Pancreatic Fistula

    the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients

    Measured: in 30 days following gastrectomy

Secondary outcomes (2)

  1. The Classification of Pancreatic Fistula

    the percentage of different grades of pancreatic fistula, including Grade BL, Grade B and Grade C

    Measured: in 30 days following gastrectomy

  2. The mortality of Grade B and C Pancreatic Fistula

    the percentage of patients died of Grade B or C pancreatic fistula

    Measured: in 30 days following gastrectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2018
  2. Study start1 Dec 2017
  3. Primary completion30 Nov 2018 (estimated)
  4. Study completion30 Nov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03391687
Sponsor's protocol ID
ZSGC-003
Status last verified
Jan 2018
First submitted
15 Dec 2017
Last updated
5 Jan 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28040257

  • 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.

    PubMed 24156038

  • 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.

    PubMed 19267237

  • 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.

    PubMed 21739317

  • 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.

    PubMed 26256914

  • 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.

    PubMed 24379588

  • 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.

    PubMed 24105422

  • 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.

    PubMed 16003309

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer and Pancreatic Fistula, run by Shanghai Zhongshan Hospital at 21 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhaoqing Tang, MD (+86-13817125778, tang.zhaoqing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Pancreatic Fistula (time frame: in 30 days following gastrectomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03391687, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.

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