First-day Versus Early Drain Removal Following PD: a Randomized Controlled Trial (NCT06468917) | Clinical Trial Compass
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First-day Versus Early Drain Removal Following PD: a Randomized Controlled Trial
Italy224 participantsStarted 2024-06-01
Plain-language 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)
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares removing the drain on the first day after surgery versus keeping it in longer — given my specific situation, which approach does my surgeon currently lean toward, and why?
2Since this trial is specifically measuring pancreas-related complications like pancreatic fistula, how would my personal risk of developing a fistula affect whether one drain timing approach might be safer for me?
3The trial's recruitment status is listed as unknown — is this study actually still enrolling patients at a center near me, or has it stopped, and what does that mean for my options?
4This trial doesn't have a traditional phase label, which suggests it's comparing two existing clinical practices rather than testing a new drug — does that mean the risks involved are similar to what I'd face with standard post-surgery care anyway?
5If I don't participate in this trial, what is the current standard practice for drain removal after my type of surgery at your hospital, and would that differ from what's being tested here?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
occurrence of one or more pancreas-specific complications