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Postoperative Endoscopic Balloon Dilatation for delayed gastric emptying after pancreatectomy (eBalloon Trial)

Postoperative Endoscopic Balloon Dilatation for delayed gastric emptying after pancreatectomy (eBalloon Trial) - eBalloon Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033024
Enrollment
30
Registered
2023-11-15
Start date
2024-03-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who underwent partial pancreatic head resection or total pancreatectomy

Interventions

Group 1: Endoscopic balloon dilatation (eBD) of the pylorus or gastrojejunostomy following partial or total pancreatectomy min. after postoperative day 5 in patients with persistent delayed gastric em

Sponsors

Universitätsklinikum Hamburg-Eppendorf (UKE), Martinistraße 52, 20246 Hamburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: - contraindication for endoscopic intervention - malcompliance - unable to sign informed consent or understand the details of the trial (e.g. language barrier)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- Date of final NGT removal (postoperative day) - Mean duration of NGT placement after endoscopy - Start of oral enteral nutrition (post interventional day) - Number and duration of endoscopic interventions - Duration of intermediate or intensive care unit stay (days) - Morbidity (in-house) according to CDC classification. - Rate of postoperative pancreatic fistula (POPF, ISGPF definition) - Proportion of pylorus-preserving resections in relation to all resections - Conservative (medical) treatment strategies used for DGE therapy

Countries

Germany

Contacts

Public ContactThilo Welsch

Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Universitätsklinikum Hamburg-Eppendorf (UKE), Martinistraße 52, 20246 Hamburg

t.welsch@uke.de+49 40741052401

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026