Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06468917

First-day Versus Early Drain Removal Following PD: a Randomized Controlled Trial

Led by Casa di Cura Dott. Pederzoli · Updated on 2024-06-21

224

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

Sponsors

C

Casa di Cura Dott. Pederzoli

Lead Sponsor

U

University of Padova

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pancreatic surgery is a complex discipline with a high risk of post-operative morbidity such as pancreatic fistula (POPF) with variable impact on clinical outcome. Controversies on ID placement have emerged from both randomized and non-randomized clinical studies investigating its possible role in increasing POPF and postoperative morbidity. The optimal timing for drain removal after PD is still a subject of debate: most studies have shown that outcomes are best when ID are removed in postoperative day (POD) 3 when POPF is excluded. AIM we aim to compare postoperative surgical outcomes after PD in patients with low/medium risk for POPF (ISGPS risk class A-B-C), who undergo POD1 drains removal versus POD3 removal. Primary aim: 1) grade B/C POPF; 2) post-pancreatectomy hemorrhage (PPH). Secondary aims: occurrence of fluid collection, sepsis, SSI, need for reintervention, length of stay, CD\>3, 90 days mortality, re-admission. Study Design: This is a randomized, controlled, open-label study. All patients will be randomized on POD1, using computer-generated randomization codes. Group A: Drain removal on POD 1 (in case of POD 1 DFA\< 300 U/L) Group B: Drain removal on POD 3 (in case of POD 1 DFA\< 300 U/L)

CONDITIONS

Official Title

First-day Versus Early Drain Removal Following PD: a Randomized Controlled Trial

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 85 years undergoing elective pancreaticoduodenectomy who provide informed consent
  • Intraoperative low to moderate risk for pancreatic fistula (ISGPS class A-B-C)
  • Postoperative day 1 drain fluid amylase (DFA) less than 300 U/L
Not Eligible

You will not qualify if you...

  • Age younger than 18 or older than 85 years
  • High risk for pancreatic fistula (ISGPS class D)
  • Placement of external or internal pancreatic stent during surgery
  • Postoperative day 1 drain fluid amylase (DFA) 300 U/L or higher
  • Drain fluid with a sinister appearance as defined in literature
  • Early post-pancreatectomy hemorrhage
  • Intraoperative conditions requiring prolonged intrabdominal drains
  • Previous bilio-pancreatic surgery
  • Allergy to drain materials
  • Significant blood clotting disorders
  • Unable to provide informed consent
  • Suspected surgery-related fistula other than pancreatic fistula

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cdcpederzoli

Peschiera del Garda, Verona, Italy, 37019

Actively Recruiting

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Research Team

I

isabella frigerio, MD

CONTACT

G

giovanni butturini, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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