Nasogastric Decompression Following Pancreaticoduodenectomy (NCT06413888) | Clinical Trial Compass
CompletedNot Applicable
Nasogastric Decompression Following Pancreaticoduodenectomy
United States230 participantsStarted 2018-06-01
Plain-language summary
Pancreaticoduodenectomy (PD) remains the gold-standard operation for peri-ampullary neoplasms. Traditionally, gastric decompression via nasogastric intubation has been employed postoperatively to prevent nausea, vomiting, aspiration pneumonia, anastomotic leakage and delayed gastric emptying. Recently, the implementation of ERAS protocol recommended against routine use of nasogastric tube following PD. however, limited data exists surrounding the identification of those patients needing NGT decompression in the immediate postoperative period. Therefore, we initiated a large prospective randomized controlled trial to evaluate the clinical outcomes of patients who retained the NGT post-PD versus those who had it removed at the end of the procedure. This study aims to assess the effectiveness of nasogastric decompression in PD recovery, with the primary endo point being the need for and impact of NGT in the postoperative recovery. The secondary endpoint will examined the re-insertion rate of NGT and identify factors that necessitate its use in the immediate postoperative period.
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:
* All patients 18 years of age or older
* Patients undergoing successful pancreaticoduodenectomy for benign or malignant neoplasm.
Exclusion Criteria:
* Patients who does not complete the procedure due to locally advanced or metastatic disease discovered during the procedure.
* Patient who requires prolong postoperative intubation in the postoperative period.
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.
1Since this trial specifically looked at whether using a nasogastric tube after a Whipple procedure reduces complications like delayed gastric emptying, can you tell me what the results showed and whether that changes how you manage patients after surgery?
2Delayed gastric emptying is listed as one of the main complications this trial was studying — how common is that after my type of surgery, and what would it mean for my recovery if it happened to me?
3Since this trial has already completed, has the data been published or shared anywhere, and would the findings influence whether I'd have a nasogastric tube placed after my Whipple procedure?
4This trial was labeled Phase NA, which I understand means it was testing a procedural approach rather than a drug — does that mean the safety picture from this kind of study is different from what I should expect from a medication trial?
5Beyond the nasogastric tube question this trial was examining, what are the other main post-operative complications I should be prepared for after a Whipple procedure, and how does your team typically manage them?
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
to assess whether nasogastric decompression following a whipple procedure will reduce the incidence and severity of postoperative complications