NCT04798560

Brief Summary

Pancreatic cancer is an aggresive type of cancer with poor mean survival rates despite improvements in chemotherapy regimens and advances in surgical techniques. Surgery is the only therapeutic option with an intend to treat. Pancreaticoduodenectomy is indicated for malignancy in the pancreatic head as well as other periampullary tumors. One of the most fatal complications after Whipple operation is postoperative pancreatic fistula as a result of pancreatojejunostomy leakage. Various risk factors for pancreatojejunostomy leakage have been proposed, while there are others less studied.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

March 2, 2021

Last Update Submit

March 11, 2021

Conditions

Pancreatic FistulaWhipple OperationPancreaticoduodenectomyPOPF

Keywords

pancreaticoduodenectomypancreatic cancerpancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Development of Postoperative pancreatic fistula after pancreaticoduodenectomy

    Following pancreaticoduodenectomy, patients are observed for developing POPF according to ISGPF definition

    30 days

Secondary Outcomes (7)

  • Mortality

    30 days

  • Morbidity

    30 days

  • Postoperative complications

    30 days

  • Duration of Hospital stay

    60 days

  • Readmission

    30 days

  • +2 more secondary outcomes

Study Arms (1)

Patients undergoing Whipple operation

After Whipple operation patients will be observed for complications and emphasis will be given on the presence of postoperative pancreatic fistula (POPF) according to the ISGPF 2016 definition. There will be to arms of patients. The first will include patients that do not develop POPF or either develop Biochemical Leak (Grade A). The second group consist of patients that develop either Grade B or Grade C POPF

Procedure: Pancreaticoduodenectomy

Interventions

PancreaticoduodenectomyPROCEDURE

Patients udergo pancreaticoduodenectomy for periampullary tumors. All of them are observed for developing POPF

Patients undergoing Whipple operation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients over 18 years of age with imaging findings or histologically proven periampullary tumors requiring pancreaticoduodenectomy

You may qualify if:

  • Age more than or equal to 18 years
  • periampullary pathologies (benign or malignant) with indication for panceaticoduodenectomy
  • Pancreaticojejunal anastomosis performed
  • Curative resection
  • Signed informed consent form -

You may not qualify if:

  • Age less than 18 years old
  • One stage total pancreatectomy
  • External wirsungostomy without pancreaticojejunal anastomosis
  • Subtotal pancreatectomy without pancreaticojejunal anastomosis
  • Left pancreatectomies
  • Intraoperatively findings of unresectable tumors
  • Pregnancy
  • Concurrent participation in other study(ies)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Propaedeutic Department of Surgery, Hippokrateion General Hospital

Athens, Attica, 11527, Greece

RECRUITING

Related Publications (6)

  • 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.

    PMID: 16003309BACKGROUND

  • 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.

    PMID: 28040257BACKGROUND

  • Cullen JJ, Sarr MG, Ilstrup DM. Pancreatic anastomotic leak after pancreaticoduodenectomy: incidence, significance, and management. Am J Surg. 1994 Oct;168(4):295-8. doi: 10.1016/s0002-9610(05)80151-5.

    PMID: 7524375BACKGROUND

  • Denbo JW, Orr WS, Zarzaur BL, Behrman SW. Toward defining grade C pancreatic fistula following pancreaticoduodenectomy: incidence, risk factors, management and outcome. HPB (Oxford). 2012 Sep;14(9):589-93. doi: 10.1111/j.1477-2574.2012.00486.x. Epub 2012 May 28.

    PMID: 22882195BACKGROUND

  • Nahm CB, Connor SJ, Samra JS, Mittal A. Postoperative pancreatic fistula: a review of traditional and emerging concepts. Clin Exp Gastroenterol. 2018 Mar 15;11:105-118. doi: 10.2147/CEG.S120217. eCollection 2018.

    PMID: 29588609BACKGROUND

  • Ryan DP, Hong TS, Bardeesy N. Pancreatic adenocarcinoma. N Engl J Med. 2014 Sep 11;371(11):1039-49. doi: 10.1056/NEJMra1404198. No abstract available.

    PMID: 25207767BACKGROUND

MeSH Terms

Conditions

Pancreatic FistulaPancreatic Neoplasms

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Dimitrios Vouros, MD, MSc

CONTACT

+30 2132088142jimsamiotis@hotmail.com

Konstantinos Toutouzas, Profesor

CONTACT

+30 6970801370tousur@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 15, 2021

Study Start

October 10, 2018

Primary Completion

April 1, 2021

Study Completion

May 1, 2022

Last Updated

March 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)