ClinicalTrials.gg
Status unknownNCT03391687Updated Jan 5, 2018

Incidence of Pancreatic Fistula After Radical Gastrectomy

An observational study in Gastric Cancer, Pancreatic Fistula and Complication, sponsored by Shanghai Zhongshan Hospital. Status unknown at 21 sites in China. Per ClinicalTrials.gov, last updated 2018-01-05.

Sponsored by Shanghai Zhongshan Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,100
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 30 studies in Stomach Neoplasms by Shanghai Zhongshan Hospital — 12 open to participants now, 13 under way, none of them phase 3. Stomach Neoplasms · Shanghai Zhongshan Hospital.

Planned enrollment
2nd of 12
2,100 · median 462
Started
2017
with 3 others
Observational
12 of 30
5 open now
Registered
11th of 30
by date

Among the 30 studies in Stomach Neoplasms by Shanghai Zhongshan Hospital, this one is the 2nd largest by planned enrollment of the 12 observational ones that give a count, is one of 4 that started in 2017, is one of 12 observational ones, and was the 11th registered.

Stomach Neoplasms

3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.

Browse Stomach Neoplasms studies →

Open to participants now

12 of the 30 studies in Stomach Neoplasms by Shanghai Zhongshan Hospital are open now, in 1 country. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

All 12 open studies →

Where they have run

Who these studies take

Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in Stomach Neoplasms by Shanghai Zhongshan Hospital, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Gastric Cancer
  • Pancreatic Fistula
  • Complication

Keywords

  • Gastric Cancer
  • Pancreatic Fistula
  • Gastrectomy
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

stomach adenocarcinoma patients who recieved radical gastrectomy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pathological confirmed stomach adenocarcinoma
  • preoperative curatively resectable tumor

Exclusion criteria

Exclusion Criteria:

  • pancreas resection
  • emergent surgery due to gastric cancer acute complications
  • cancer of gastric remnant
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Amylase Test

    gastric cancer patients receiving radical gastrectomy

    Diagnostic Test: Amylase Test

Interventions

  • Diagnostic testAmylase Test

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

06

What researchers measure

Primary outcomes

  1. Incidence of Pancreatic Fistula

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

    Time frame: in 30 days following gastrectomy

Secondary outcomes

  1. The Classification of Pancreatic Fistula

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

    Time frame: 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

    Time frame: in 30 days following gastrectomy

07

Study locations

21 of 21 sites recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing, China
    Recruiting
    • Ziyu Li, MD · Contact
    • Ziyu Li, MD · Principal investigator
  • Beijing Chao-Yang Hospital
    Beijing, Beijing, China
    Recruiting
    • Minzhe Li, MD · Contact
    • Minzhe Li, MD · Principal investigator
  • South West Hospital
    Chongqing, Chongqing, China
    Recruiting
    • Yingxue Hao, MD · Contact
    • Yingxue Hao, MD · Principal investigator
  • South West Hospital
    Chongqing, Chongqing, China
    Recruiting
    • Yongliang Zhao, MD · Contact
    • Yongliang Zhao, MD · Principal investigator
  • Fujian Cancer Hospital
    Fuzhou, Fujian, China
    Recruiting
    • Weidong Zang, MD · Contact
    • Weidong Zang, MD · Principal investigator
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian, China
    Recruiting
    • Chaohui Zheng, MD · Contact
    • Chaohui Zheng, MD · Principal investigator
  • Guangdong General Hospital
    Guangzhou, Guangdong, China
    Recruiting
    • Yong Li, MD · Contact
    • Yong Li, MD · Principal investigator
  • The First Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China
    Recruiting
    • Wu Song, MD · Contact
    • Wu Song, MD · Principal investigator
  • Henan Cancer Hospital
    Zhengzhou, Henan, China
    Recruiting
    • Zhi Li, MD · Contact
    • Zhi Li, MD · Principal investigator
  • Jiangsu Province Hospital
    Nanjing, Jiangsu, China
    Recruiting
    • Li Yang, MD · Contact
    • Li Yang, MD · Principal investigator
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi, China
    Recruiting
    • Zhengrong Li, MD · Contact
    • Zhengrong Li, MD · Principal investigator
  • The Second Hospital of Jilin University
    Changchun, Jilin, China
    Recruiting
    • Jiaming Zhu, MD · Contact
    • Jiaming Zhu · Principal investigator
  • Affiliated Hospital of Qinghai University
    Xining, Qinghai, China
    Recruiting
    • Su Yan, MD · Contact
    • Su Yan, MD · Principal investigator
  • Weifang People's Hospital
    Weifang, Shandong, China
    Recruiting
    • Jianjun Qu, MD · Contact
    • Jianjun Qu, MD · Principal investigator
  • ZhongShan hospital Fudan university
    Shanghai, Shanghai 200032, China
    Recruiting
  • Renji Hospital, Shanghai Jiaotong University
    Shanghai, Shanghai, China
    Recruiting
    • Gang Zhao, MD · Contact
    • Gang Zhao, MD · Principal investigator
  • Ruijing Hospital, Shanghai Jiaotong University
    Shanghai, Shanghai, China
    Recruiting
    • Junjun Ma, MD · Contact
    • Zang Lu, MD · Contact
    • Junjun Ma, MD · Sub investigator
    • Zang Lu, MD · Principal investigator
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shanxi, China
    Recruiting
    • Lin Fan, MD · Contact
    • Lin Fan, MD · Principal investigator
  • The First Affiliated Hospital of Xinjiang Medical University
    Ürümqi, Xinjiang, China
    Recruiting
    • Wenbin Zhang, MD · Contact
    • Wenbin Zhang, MD · Principal investigator
  • Hangzhou First People's Hospital
    Hangzhou, Zhejiang, China
    Recruiting
    • Jian Zhang, MD · Contact
    • Jian Zhang, MD · Principal investigator
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicince
    Hangzhou, Zhejiang, China
    Recruiting
    • Linghua Zhu, MD · Contact
    • Linghua Zhu, MD · Principal investigator
08

References and documents

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. Erratum In: Surgery. 2024 Sep;176(3):988-989. doi: 10.1016/j.surg.2024.05.043. 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2017 (actual). Primary completion is estimated for Nov 2018, 11 months after the start.

Of 323 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 171. This study's planned 11 months is below that.

Counting every sponsor, half of 365 studies reached it within 54 months; a quarter within 29 and three quarters within 119.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2017
First posted
Jan 5, 2018
StartActual
Dec 1, 2017
Primary completionEst.
Nov 30, 2018
CompletionEst.
Nov 30, 2018
Last update
Jan 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03391687
Responsible party
Sponsor
First posted
Jan 5, 2018
Start date
Dec 1, 2017
Primary completion
Nov 30, 2018 (estimated)
Completion
Nov 30, 2018 (estimated)
Last update
Jan 5, 2018

Study contacts

Zhaoqing Tang, MD
Contact
tang.zhaoqing@zs-hospital.sh.cn
+86-13817125778
Fenglin Liu, MD
principal investigator · Fudan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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