Comparing early versus delayed drain removal after pancreatic surgery
First-day Versus Early Drain Removal Following Pancreaticoduodenectomy: a Randomized Controlled Trial
This study is testing if taking out drains a day after pancreatic surgery instead of three days later can lead to better recovery for patients at low to medium risk for complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Casa di Cura Dott. Pederzoli Academic / other |
| Locations | 1 site (Peschiera del Garda, Verona) |
| Trial ID | NCT06468917 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the outcomes of early drain removal on the first postoperative day (POD1) compared to the standard removal on POD3 in patients undergoing pancreaticoduodenectomy. It focuses on patients at low to medium risk for developing pancreatic fistula, assessing various postoperative complications such as pancreatic fistula grade B/C and post-pancreatectomy hemorrhage. The study is randomized and controlled, ensuring a robust comparison of surgical outcomes between the two groups. The trial will also monitor secondary outcomes including fluid collection, sepsis, and length of hospital stay.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 undergoing elective pancreaticoduodenectomy with a low to moderate risk for pancreatic fistula.
Not a fit: Patients with a high risk of developing pancreatic fistula or those with certain intraoperative conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and reduced complications for patients undergoing pancreatic surgery.
How similar studies have performed: Previous studies have shown mixed results regarding drain management in pancreatic surgery, indicating that this approach may provide new insights into optimal postoperative care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Peschiera del Garda, Verona
- Cdcpederzoli — Peschiera del Garda, Verona, Italy (Recruiting)
Study contacts
- Principal investigator: isabella frigerio, MD — Casa di Cura Dott. Pederzoli
- Study coordinator: isabella frigerio, MD
- Email: isabella.frigerio@ospedalepederzoli.it
- Phone: 00390456449187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.