Endoscopic versus conservative management in the treatment of postoperative pancreatic fistula after distal pancreatectomy (Endo-POPF) – A randomized controlled pilot trial

Endoscopic versus conservative management in the treatment of postoperative pancreatic fistula after distal pancreatectomy (Endo-POPF) – A randomized controlled pilot trial - Endo-POPF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015765

Enrollment

Registered

2018-10-22

Start date

2018-11-01

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

C25.2 T81.8

Interventions

Group 1: After randomisation, endoscopic examination and treatment (i.e. endoscopic retrograde pancreatography (ERP), sphincterotomy and implantation of a prosthesis, if possible) Group 2: No endosco

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients with (persistent) biochemical leak/POPF following DP, fulfilling one of the following criteria: a) If abdominal drain is placed intraoperatively: Persistent drainage of amylase-rich fluid (according to the updated ISGPS definition) on or after POD 8 or b) If no abdominal drain is placed intraoperatively: Application of percutaneous drainage system due to POPF on or after POD 8 with drainage of amylase-rich fluid (according to the updated ISGPS definition) ongoing after the first 24 hours; =18 years of age; Written informed consent; Ability of subject to understand character and individual consequences of the clinical trial

Exclusion criteria

Exclusion criteria: Anatomical situation which makes duodenoscopy impossible/difficult; American Society of Anesthesiologists (ASA) score >III; Pregnancy or lactation; Understanding or language problems; Inability to comply with study and/or follow-up procedures; Known allergy or intolerability to contrast agents; Any condition which could result in an undue risk for the patient in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
To evaluate the feasibility of a randomized controlled trial (RCT) comparing endoscopic versus conservative management in the treatment of POPF after DP. Further objective is to gain first RCT data on the safety and efficacy of endoscopic versus conservative management in POPF treatment.	—

Secondary

Measure	Time frame
Frequency of primary POPF closure, Duration of POPF, POPF recurrence, Endoscopic technical success/feasibility, ERP-associated complications, Number of ERPs per patient, New onset of postpancreatectomy haemorrhage, New onset of POPF-related abscess/infected POPF, Relaparotomy/-laparoscopy, Reintervention (other than ERP), Mortality, Duration of intermediate/intensive care unit stay, Duration of postoperative hospital stay, Readmissions to hospital	—

Measure

Time frame

Frequency of primary POPF closure, Duration of POPF, POPF recurrence, Endoscopic technical success/feasibility, ERP-associated complications, Number of ERPs per patient, New onset of postpancreatectomy haemorrhage, New onset of POPF-related abscess/infected POPF, Relaparotomy/-laparoscopy, Reintervention (other than ERP), Mortality, Duration of intermediate/intensive care unit stay, Duration of postoperative hospital stay, Readmissions to hospital

—

Countries

Germany

Contacts

Public ContactUlla Klaiber

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie/Department of General, Visceral and Transplantation Surgery

Ulla.Klaiber@med.uni-heidelberg.de062215635242

Outcome results

None listed

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