An open, single center, single-arm phase II study to evaluate the safety of a modificated perioperative analgesia with Indometacin during pancreaticoduodenectomy

An open, single center, single-arm phase II study to evaluate the safety of a modificated perioperative analgesia with Indometacin during pancreaticoduodenectomy - InPaFis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011321

Enrollment

Registered

2017-06-30

Start date

2017-09-21

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

MedDRA - 10045751 (Unspecified disease of pancreas)

Interventions

Group 1: Application of 100 mg Indometacin (rectal) before and after a pancreaticoduodenectomy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years 2. Indication for pancreatoduodenectomy 3. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Perioperative application of platelet aggregation inhibitors 2. Application of other NSARs 3. Application of selective serotonin reuptake inhibitors, Triamteren oder Diflunisal 4. Preexisting ischemic heart disease 5. Preexisting peripheral arterial disease 6. Preexisting cerebrovascular disease 7. Morbus Crohn 8. Colitis ulcerosa 9. Pregnancy and breast-feeding 10. Persons of child-bearing potential not willing or able to use safe methods of contraception 11. Preexisting allergies on other substances, pollen or allergic asthma 12. Limited legal competence 13. Participation in another intervential trial that could interfere with the treatment or outcome of this study

Design outcomes

Primary

Measure	Time frame
Severe postoperative complications (>= grade IV according to the Clavien-Dindo-classification) until 6 weeks after pancreatoduodenectomy with application of Indometacin	—

Secondary

Measure	Time frame
1.) Surgical quality characteristic: Mortality, bleeding according to ISGPF grade a, b, c; Delayed gastric emptying according to ISGPF grade a, b, c; Pancreatic fistula according to ISGPF grade a, b, c; Rate of reoperations; Need of salvage pancreatectomy; Abcessus with need of therapy. 2.) Non-surgical comlications: Septic shock respiratory failure deep vein thrombosis pulmonary embolism Myocardial infaction stroke 3.) Perioperative quality characteristics: Operation time (incision-suture) Days on ICU Readmission on ICU Days of hospitalization 4.) Safety: AEs SAEs	—

Measure

Time frame

1.) Surgical quality characteristic: Mortality, bleeding according to ISGPF grade a, b, c; Delayed gastric emptying according to ISGPF grade a, b, c; Pancreatic fistula according to ISGPF grade a, b, c; Rate of reoperations; Need of salvage pancreatectomy; Abcessus with need of therapy. 2.) Non-surgical comlications: Septic shock respiratory failure deep vein thrombosis pulmonary embolism Myocardial infaction stroke 3.) Perioperative quality characteristics: Operation time (incision-suture) Days on ICU Readmission on ICU Days of hospitalization 4.) Safety: AEs SAEs

—

Countries

Germany

Contacts

Public ContactOlivia Sick

Universitätsklinikum FreiburgAbteilung Allgemein- und Viszeralchirurgie

olivia.sick@uniklinik-freiburg.de0761/270-2808

Outcome results

None listed

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