Identifing Risk Factors for Pancreaticojejunostomy Leakage Following Pancreaticoduodenectomy

• Conditions: Pancreaticoduodenectomy; Pancreatic Fistula; POPF; Whipple Operation
• Interventions: Procedure: Pancreaticoduodenectomy

• Registration Number: NCT04798560
• Lead Sponsor: Dimitrios Vouros

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.

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 Timeline

• Study Start: 2018-10-10
• Status Verified: 2021-03
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-11
• Last Update Submitted: 2021-03-11
• Study First Posted: 2021-03-15
• Last Update Posted: 2021-03-15
• Primary Completion: 2021-04
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing Whipple operation	Pancreaticoduodenectomy	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

Primary Outcome Measures

Name	Time	Method
Development of Postoperative pancreatic fistula after pancreaticoduodenectomy	30 days	Following pancreaticoduodenectomy, patients are observed for developing POPF according to ISGPF definition

Secondary Outcome Measures

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

Trial Locations

Locations (1)

1st Propaedeutic Department of Surgery, Hippokrateion General Hospital; 🇬🇷 Athens, Attiki, Greece