POPF-Prevent - Intestinal vacuum therapy for the prevention of postoperative pancreatic fistula A feasibility trial In partial pancreatoduodenectomy with reconstruction by pancreatojejunostomy (Lomgmire-Traverso), intraoperative transnasal insertion of a negative pressure drain wrapped with Suprasorb foil into the biliodigestive loop at the level of the pancreatojejunostomy. Continuous suction treatment for 5 (-7) days (critical phase of anastomosis healing) with active drainage of pancreatic juice and bile and utilization of the positive effects of Vacuseal therapy on anastomosis healing. Transnasal removal of the tube by manual traction.

POPF-Prevent - Intestinal vacuum therapy for the prevention of postoperative pancreatic fistula A feasibility trial In partial pancreatoduodenectomy with reconstruction by pancreatojejunostomy (Lomgmire-Traverso), intraoperative transnasal insertion of a negative pressure drain wrapped with Suprasorb foil into the biliodigestive loop at the level of the pancreatojejunostomy. Continuous suction treatment for 5 (-7) days (critical phase of anastomosis healing) with active drainage of pancreatic juice and bile and utilization of the positive effects of Vacuseal therapy on anastomosis healing. Transnasal removal of the tube by manual traction. - POPF-Prevent

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037185

Enrollment

Registered

2025-10-21

Start date

2026-06-23

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

C25.0 D13.6 K86

Interventions

Group 1: 20 consecutive patients with pancreatic head resection (regardless of indication) and reconstruction by pancreatojejunostomy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Pathological (resectable) findings in the pancreatic head with indication for pancreatic head resection (benign and malignant tumors, chronic pancreatitis) and intraoperative decision to create an end-to-side pancreato-jejunostomy.

Exclusion criteria

Exclusion criteria: Lack of patient consent. Minors. Adults unable to give consent. Emergency intervention. Pregnant women.

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is to demonstrate the intraoperative technical feasibility of the safe placement and subsequent postoperative problem-free removal of an actively aspirated negative pressure probe in the biliodigestive loop and the correct retention of the probe in the anastomotic region during the critical phase of anastomotic healing. The combined primary endpoint is thus the problem-free placement and removal of the probe and its correct retention at the desired location.	—

Measure

Time frame

The primary objective of the study is to demonstrate the intraoperative technical feasibility of the safe placement and subsequent postoperative problem-free removal of an actively aspirated negative pressure probe in the biliodigestive loop and the correct retention of the probe in the anastomotic region during the critical phase of anastomotic healing. The combined primary endpoint is thus the problem-free placement and removal of the probe and its correct retention at the desired location.

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Secondary

Measure	Time frame
Secondary endpoints are postoperative mortality, morbidity and anastomotic insufficiency rate (according to the POPF definition (Bassi et al. 2017)). Patient safety aspects are also of interest: bleeding rate from the pancreatic resection area, electrolyte shifts with the occurrence of metabolic acidosis due to loss of electrolytes and bicarbonate through active drainage of the pancreatic secretion or possible bowel wall erosion due to the inserted drainage.	—

Measure

Time frame

Secondary endpoints are postoperative mortality, morbidity and anastomotic insufficiency rate (according to the POPF definition (Bassi et al. 2017)). Patient safety aspects are also of interest: bleeding rate from the pancreatic resection area, electrolyte shifts with the occurrence of metabolic acidosis due to loss of electrolytes and bicarbonate through active drainage of the pancreatic secretion or possible bowel wall erosion due to the inserted drainage.

—

Countries

Germany

Contacts

Public ContactFred Christian Biber

Klinikum Fulda

fred-christian.biber@klinikum-fulda.de+49661845617

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026