Post-Operative Acute Pancreatitis After Pancreaticoduodenectomy (NCT04917172) | Clinical Trial Compass
CompletedNot Applicable
Post-Operative Acute Pancreatitis After Pancreaticoduodenectomy
Italy65 participantsStarted 2019-04-10
Plain-language summary
The occurrence of post-pancreatectomy acute pancreatitis (PPAP) can critically impact outcomes after pancreaticoduodenectomy. Although diagnosing a PPAP can be challenging, its identification appears crucial as it can trigger additional morbidity. However, due to the early onset in the perioperative period, the actual spectrum of its early phases has not been systematically explored yet. For this reason, the present study will compare some early biochemical evidence of pancreatic stump damage to morphological changes evident at postoperative imaging.
The postoperative evaluation of serum and/or urine pancreatic enzymes and the radiologic assessment are included in everyday clinical practice. However, the timing and the clinical relevance of such findings mostly rely on the single-institution experience.
This study aims to characterize PPAP by investigating its early radiologic, biochemical, and clinical spectrum of either local or systemic changes associated.
Who can participate
Age range
18 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:
* Male and females ≥ 18 years;
* Scheduled for elective PD;
* ASA score \< 4;
* High-quality preoperative cross-sectional imaging of the abdomen performed roughly within one month before surgery;
* Upfront or after neoadjuvant therapy surgery is allowed;
* Ability of the subject to understand the character and individual consequences of the clinical trial;
* Written informed consent.
Exclusion Criteria:
* Patients undergoing emergency surgery;
* Patients with high serum pancreatic amylase or lipase before surgery;
* Chronic use of steroids;
* Informed consent withdrawal;
* Pancreaticogastrostomy (PG);
* Use of octreotide analogs;
* Inability to perform the resection for any reason;
* Total or distal pancreatectomy;
* Need to extend the resection to the pancreas body for any reason.
* Inability to undergo MRI because of contraindications (e.g. claustrophobia, presence of non-MRI-compatible metal implants)
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
the difference in apparent diffusion coefficient (ADC) values at diffusion-weighted (DW) MRI in the PPAP group compared to patients without PPAP.
Timeframe: postoperative day 3 (72 h after the index surgery).