Identifing Risk Factors for Pancreaticojejunostomy Leakage Following Pancreaticoduodenectomy

March 11, 2021 updated by: Dimitrios Vouros

Risk Factors for Pancreaticojejunostomy Leakage Following Whipple Operation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational study conducted in the 1st Propaedeutic Department of Surgery of the National and Kapodistrian University of Athens, Greece. Patients with imaging and/or histologically proven periampullary tumors in which Whipple operation is indicated will be enrolled in the study after signing a consent designed by the Hospitals Ethics Commitee and the Department of Surgery. Patients information and medical history will be recorded, giving emphasis on clinical presentation, signs and symptoms related to the patients disease. Laboratory tests will afterwards take place, including biochemical parameters such as total bilirubin levels, serum albumin, CA 19-9, CEA, HbA1c and ferritine levels prior to operation. During operation, as soon as the specimen has been removed, the horizontal and vertical dimension of the pancreatic cutting surface will be measured with the use of an one use sterile ruler and the area of the cutting surface will then be calculated as well as the ratio of the two dimensions (horizontal/vertical). The diameter of the pancreatic duct will be measured either with the same ruler in case diameter is equal or greater than 3mm or with a use of a plastic stent in case diameter is less than 3mm. Pancreatic texture will also be assesed. Other intraoperative datas will be recorded such as the anastomosis technique, duration of surgery, amount of fluid administration, transfusion with fresh frosen plasma or blood units.Postoperatively, amylase from the drains, white blood cell count, platelet count and serum crp levels will be recorded on the 1st, 3rd and 5th postoperative day in all patients. The definition used for postoperative pancreatic fistula (POPF) is based on the International Study Group of Pancreatic Fistula 2016 definition and patients will be categorised accordingly. There will be two arms of patients. The first arm will include patients with either no POPF or Biochemical Leak (BL) and the second arm patients with Grade B or C POPF.

Any complication in the early postoperative period ,defined as the first 30 days after Whipple operation, will be recorded and categorised according to Clavien Dindo classification, including reoperation, readmissions or prolongation of hospital stay. After discharge, follow up of the patients include the EORTC QLQ-C30 and EORTC QLQ-PAN 26 questionnaires that patients have to fill in one, three, six and twelve months after surgery. Reccurence and survival rates will accordingly be recorded.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Konstantinos Toutouzas, Profesor
  • Phone Number: +30 6970801370
  • Email: tousur@hotmail.com

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 11527
        • Recruiting
        • 1st Propaedeutic Department of Surgery, Hippokrateion General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Age less than 18 years old
  2. One stage total pancreatectomy
  3. External wirsungostomy without pancreaticojejunal anastomosis
  4. Subtotal pancreatectomy without pancreaticojejunal anastomosis
  5. Left pancreatectomies
  6. Intraoperatively findings of unresectable tumors
  7. Pregnancy
  8. Concurrent participation in other study(ies)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Patients udergo pancreaticoduodenectomy for periampullary tumors. All of them are observed for developing POPF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of Postoperative pancreatic fistula after pancreaticoduodenectomy
Time Frame: 30 days
Following pancreaticoduodenectomy, patients are observed for developing POPF according to ISGPF definition
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
Mortality rates expressed in % of the patients
30 days
Morbidity
Time Frame: 30 days
Morbidity rates expressed in % of the patients
30 days
Postoperative complications
Time Frame: 30 days
Complications classified according to Clavien-Dindo Classification taking measures from I up to V
30 days
Duration of Hospital stay
Time Frame: 60 days
Duration of Hospital stay in days
60 days
Readmission
Time Frame: 30 days
Readmission rates expressed in % of the patients
30 days
Reoperation
Time Frame: 30 days
Reoperation rates expressed in % of the patients
30 days
Overall survival
Time Frame: 2 years
Estimation of days from operation until death expressed in days
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dimitrios Vouros

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2018

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8515/31-05-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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