2018-10-10
2021-04
2022-05
100
NCT04798560
University of Athens
University of Athens
OBSERVATIONAL
Identifing Risk Factors for Pancreaticojejunostomy Leakage Following Pancreaticoduodenectomy
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-03-02 | N/A | 2021-03-11 |
2021-03-11 | N/A | 2021-03-15 |
2021-03-15 | N/A | 2021-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | 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 pat | PROCEDURE: Pancreaticoduodenectomy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Development of Postoperative pancreatic fistula after pancreaticoduodenectomy | Following pancreaticoduodenectomy, patients are observed for developing POPF according to ISGPF definition | 30 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Mortality | Mortality rates expressed in % of the patients | 30 days |
| Morbidity | Morbidity rates expressed in % of the patients | 30 days |
| Postoperative complications | Complications classified according to Clavien-Dindo Classification taking measures from I up to V | 30 days |
| Duration of Hospital stay | Duration of Hospital stay in days | 60 days |
| Readmission | Readmission rates expressed in % of the patients | 30 days |
| Reoperation | Reoperation rates expressed in % of the patients | 30 days |
| Overall survival | Estimation of days from operation until death expressed in days | 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Dimitrios Vouros, MD, MSc Phone Number: +30 2132088142 Email: jimsamiotis@hotmail.com |
Study Contact Backup Name: Konstantinos Toutouzas, Profesor Phone Number: +30 6970801370 Email: tousur@hotmail.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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