Investigator-Initiiated Intraoperative Pancreatic Leakage Indicator Exploratory Randomized Controlled Multicenter Trial (IDEAL Stage IIb) - mViP

Investigator-Initiiated Intraoperative Pancreatic Leakage Indicator Exploratory Randomized Controlled Multicenter Trial (IDEAL Stage IIb) - mViP - mViP

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035254

Enrollment

100

Registered

2024-12-17

Start date

2025-04-16

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

K86.8

Interventions

Group 1: Usage of SmartPAN® indicator with targeted closure of leakage sites in case of positive indicator reaction during distal pancreatectomy. Group 2: Usage of SmartPAN® indicator without targete

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Planned distal pancreatectomy for any indication including minimally invasive and open surgery and including multivisceral resection. 2. Age = 18 years 3. Ability of subject to understand character and individual consequences of the clinical trial. 4.Written informed consent

Exclusion criteria

Exclusion criteria: 1. American Society of Anesthesiologists (ASA) Score > 3 2. Pregnancy or lactation 3. Allergy or known intolerability to bromothymol blue or potato starch 4. Participation in another interventional trial with interference of intervention or outcome of this study 5. Any condition which could result in an undue risk for the patient in the opinion of the investigator 6. Expected lack of compliance or language problems

Design outcomes

Primary

Measure	Time frame
Rate of clinically relevant grade B and C postoperative pancreatic fistula within 30 days after the index operation as defined by updated 2016 ISGPF consensus guidelines.	—

Secondary

Measure	Time frame
- Rate of biochemical leak (former pancreatic fistula grade A) within 30 days after the index operation as defined by updated 2016 ISGPF consensus guidelines. - SmartPAN®-indicator reaction: characterized by number of leaks, dimension of leaks and color intensity documented by intraoperative color photography of the pancreatic remnant in intervention and control group. The photo must contain a size scale. - Frequencies of serious intraoperative complications and major postoperative complications (Clavien-Dindo grade III to V) within 30 days after the index operation including information on potential relation to usage of the trial device. - Rate of non-surgical re-interventions within 30 days from index operation. - Rate of re-operations within 30 days from index operation.	—

Measure

Time frame

- Rate of biochemical leak (former pancreatic fistula grade A) within 30 days after the index operation as defined by updated 2016 ISGPF consensus guidelines. - SmartPAN®-indicator reaction: characterized by number of leaks, dimension of leaks and color intensity documented by intraoperative color photography of the pancreatic remnant in intervention and control group. The photo must contain a size scale. - Frequencies of serious intraoperative complications and major postoperative complications (Clavien-Dindo grade III to V) within 30 days after the index operation including information on potential relation to usage of the trial device. - Rate of non-surgical re-interventions within 30 days from index operation. - Rate of re-operations within 30 days from index operation.

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Countries

Germany, Netherlands

Contacts

Public ContactThomas Pausch

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Heidelberg

thomas.pausch@med.uni-heidelberg.de+49 6221 56 37461

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026