RecruitingNot ApplicableNCT06468917

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

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


Sponsor

Casa di Cura Dott. Pederzoli

Enrollment

224 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria3

  • Patients (age ≥ 18 or < 85 years) undergoing elective pancreaticoduodenectomy providing informed consent.
  • Intraoperative low to moderate risk for POPF (ISGPS class A-B-C)
  • POD 1 DFA < 300U/L

Exclusion Criteria12

  • Age <18 or >85
  • Patients with high risk of developing pancreatic fistula (ISGPS class D)
  • Intraoperative positioning of external or internal pancreatic stent
  • POD 1 DFA ≥300
  • Sinister appearance of drain effluent (defined as dark brown to clear "spring water" fluid that looks like pancreatic juice contaminated) as mentioned in literature3-22
  • Early post-pancreatectomy hemorrhage
  • Intraoperative conditions different from POPF risk, requiring prolonged intrabdominal drains
  • Previous bilio/pancreatic surgery
  • Allergy to drain materials
  • Significant coagulation disorders
  • Patients unable to provide informed consent.
  • Clinical suspect of another surgery-related fistula different than POPF

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Interventions

BEHAVIORAL1st day removal of abdominal drain

once POPF is excluded in middle-low risk pancreatic resection, abdominal drains can be removed


Locations(1)

Cdcpederzoli

Peschiera del Garda, Verona, Italy

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NCT06468917