NCT06413888Completed
Nasogastric Decompression Following Pancreaticoduodenectomy
Routine Nasogastric Drainage vs. No Drainage Using Nasogastric Tube After Pancreaticoduodenectomy: A Randomized Control Trial [NCT ID Not Yet Assigned]
Source: ClinicalTrials.gov · Last updated 14 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 230 (actual)
- First submitted
- 7 May 2024
- Start date
- 1 Jun 2018
- Primary completion date
- 31 May 2023
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Pancreatic cancer
- NCT number
- NCT06413888
What you commit to
- Study type: Interventional
- Participants enrolled: 230
- From 1 Jun 2018 to the primary completion date, 31 May 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients who does not complete the procedure due to locally advanced or metastatic disease discovered during the procedure.
Other
- Patient who requires prolong postoperative intubation in the postoperative period.
Who the study is looking for
- All patients 18 years of age or older
- Patients undergoing successful pancreaticoduodenectomy for benign or malignant neoplasm.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.