Postoperative Endoscopic Balloon Dilatation for delayed gastric emptying after pancreatectomy (eBalloon Trial)
Not Applicable
Recruiting
- Conditions
- Patients who underwent partial pancreatic head resection or total pancreatectomy
- Registration Number
- DRKS00033024
- Lead Sponsor
- niversitätsklinikum Hamburg-Eppendorf (UKE), Martinistraße 52, 20246 Hamburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Patients who underwent open or minimally-invasive partial pancreatectomy or total pancreatectomy using a gastrojejunostomy or duodenojejunostomy for treatment of benign or malignant diseases of the pancreas.
Exclusion Criteria
- contraindication for endoscopic intervention
- malcompliance
- unable to sign informed consent or understand the details of the trial (e.g. language barrier)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean secretion of the nasogastric tube (NGT) during the two days after trial intervention compared with the mean NGT secretion during 3 days before intervention.
- Secondary Outcome Measures
Name Time Method - Date of final NGT removal (postoperative day)<br>- Mean duration of NGT placement after endoscopy<br>- Start of oral enteral nutrition (post interventional day)<br>- Number and duration of endoscopic interventions<br>- Duration of intermediate or intensive care unit stay (days)<br>- Morbidity (in-house) according to CDC classification.<br>- Rate of postoperative pancreatic fistula (POPF, ISGPF definition)<br>- Proportion of pylorus-preserving resections in relation to all resections<br>- Conservative (medical) treatment strategies used for DGE therapy