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Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy

ConditionPancreaticoduodenectomy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorAssiut University

About this trial

Postoperative pancreatic fistula (POPF) especially clinically relevant POPF (CR-POPF; Grades B and C) is one of the critical and challenging post pancreaticoduodenectomy complications. Despite advances in surgical techniques, perioperative care, and centralization of pancreatic surgery Postoperative pancreatic fistula (POPF) remains an important cause for postoperative morbidity and

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥18 years).

Elective pancreaticoduodenectomy.

Benign or malignant periampullary and pancreatic lesions.

Disqualifiers

- Total pancreatectomy.

Distal pancreatectomy.

Missing essential preoperative data.

Death within 24 hours after surgery.

Trial population

Patients undergoing elective pancreaticoduodenctomy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • pancreaticoduodenectomy

    Procedure/Surgery

    preoperative risk model for clinically relevant postoperative pancreatic fistula by incorporation of preoperative PNI and pancreatic texture assessment by elastography with previously emerged scores in patients undergoing pancreaticoduodenectomy

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: preoperative risk model for clinically relevant postoperative pancreatic fistula1 intervention

Trial outcomes

Primary outcomes

1

Incidence of clinically relevant postoperative pancreatic fistula

Proportion of patients developing clinically relevant postoperative pancreatic fistula (Grade B or C) following pancreaticoduodenectomy, according to the International Study Group of Pancreatic Surgery (ISGPS) definition.

Time frame
Within 90 days after surgery
2

Discrimination of the preoperative prediction model

Area under the receiver operating characteristic curve (AUROC) for the preoperative prediction model in predicting clinically relevant postoperative pancreatic fistula.

Time frame
Within 90 days after surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: