Prospective open-label monocenter clinical trial to evaluate the safety and efficacy of a 2-octyl cyanoacrylate (2-OCA) bonding of the pancreatic remnant in the prevention of postoperative pancreatic fistula after distal pancreatic resection – the BOND-Trial

Prospective open-label monocenter clinical trial to evaluate the safety and efficacy of a 2-octyl cyanoacrylate (2-OCA) bonding of the pancreatic remnant in the prevention of postoperative pancreatic fistula after distal pancreatic resection – the BOND-Trial - BOND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007915

Enrollment

Registered

2015-04-09

Start date

2015-04-21

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 K86

Interventions

Group 1: Application of the sealant ETHICON(R) OMNEX(R) on the pancreatic remnant after distal pancreatic resection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Patients scheduled for elective distal pancreatic resection (DP) • = 18 years of age • Written informed consent

Exclusion criteria

Exclusion criteria: • Haemoglobin 3 times ULN • AST or ALT > 4 ULN • INR > 1.7 • Creatinine clearance III • Immunosuppressive therapy (cortison = 40 mg/d or equivalent; azathioprin) • Pregnancy or lactation • Drug trial participation within 30 days before screening visit • Understanding or language problems • Inability to comply with study and/or follow-up procedures • Allergy or known intolerability to 2-OCA, butyl-lactoyl cyanoacrylate or formaldehyde • Any condition which could result in an undue risk for the patient in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
Frequency of (serious) adverse events and (serious) adverse device effects until 3 months postoperative	—

Secondary

Measure	Time frame
frequency of postoperative pancreatic fistula (according to the ISGPF definition) frequency of other complications Duration of surgery length of postoperative hospital stay	—

Countries

Germany

Contacts

Public ContactStudienzentrum der Deutschen Gesellschaft für Chirurgie

am Universitätsklinikum Heidelberg

sdgc@med.uni-heidelberg.de06221 - 56 6986

Outcome results

None listed

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