Impact of preoperative endoscopic pyloric dilatation on postoperative gastric emptying after pylorus-preserving pancreaticoduodenectomy

Impact of preoperative endoscopic pyloric dilatation on postoperative gastric emptying after pylorus-preserving pancreaticoduodenectomy - DIGNITY

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035083

Enrollment

Registered

2024-10-09

Start date

2025-01-02

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

C25

Interventions

Group 1: All study participants receive a preoperative EPD as part of a gastroscopy on the day of admission to hospital, usually 1 day before the planned operation. The pylorus is dilated twice for 1

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age = 18 years - Indication for elective pylorus-preserving pancreaticoduodenectomy - Open surgical removal of the pancreatic head (resection) for malignant tumors and/or cysts of the pancreatic head - ASA I-III - Verbal and written informed consent - Ability to understand and implement the content and scope of the study

Exclusion criteria

Exclusion criteria: - Emergency PPPD - Pylorus resection or Whipple operation - Participation in another study that affects the study result - > ASA III - Chronic pancreatitis, - ECOG > II, - Chronic pain syndromes that require routine analgesic therapy - Participation in an interventional study

Design outcomes

Primary

Measure	Time frame
Evaluation of the efficacy of endoscopic pyloric dilatation in reducing the incidence of postoperative gastric emptying delay after PPPD	—

Secondary

Measure	Time frame
- Postoperative intervention rate (CT/ultrasound-guided punctures of an intra-abdominal obstruction) - Reoperation rate - OP-specific morbidity (within the hospital stay and 30 days postoperatively) o Postoperative complications classified according to the Clavien-Dindo classification - Mortality (within the hospital stay and 30 days postoperatively) - Length of stay IMC/ITS - Length of hospital stay - Additional interventional therapies required (e.g. endoscopic procedures, insertion of a gastric tube or feeding tube)	—

Measure

Time frame

- Postoperative intervention rate (CT/ultrasound-guided punctures of an intra-abdominal obstruction) - Reoperation rate - OP-specific morbidity (within the hospital stay and 30 days postoperatively) o Postoperative complications classified according to the Clavien-Dindo classification - Mortality (within the hospital stay and 30 days postoperatively) - Length of stay IMC/ITS - Length of hospital stay - Additional interventional therapies required (e.g. endoscopic procedures, insertion of a gastric tube or feeding tube)

—

Countries

Germany

Contacts

Public ContactBenjamin Müssle

Uniklinik Ulm, Klinik für Allgemein- und Viszeralchirurgie

benjamin-moritz.muessle@uniklinik-ulm.de+49 73150053500

Outcome results

None listed

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