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

Phase 3

• Conditions: C25.2; T81.8; Tail of pancreas; Other complications of procedures, not elsewhere classified

• Registration Number: DRKS00015765
• Lead Sponsor: Heidelberger Stiftung Chirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>