Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTokyo University
About this trial
This multicenter prospective observational registry will evaluate the clinical characteristics and treatment outcomes of adults with local complications of acute pancreatitis or postoperative pancreatic fistula. Data generated during routine clinical care, including patient characteristics, imaging findings, treatments, adverse events, recurrence, and clinical outcomes, will be collected. Treatment is determined by the treating physicians and is not assigned by the study protocol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Diagnosed with a local complication of acute pancreatitis, including acute exacerbation of chronic pancreatitis, or postoperative pancreatic fistula requiring routine clinical management.
Receiving inpatient or outpatient care at a participating institution.
Disqualifiers
Considered unsuitable for participation by the treating investigator.
Declines participation through the opt-out process.
Trial population
Adults receiving routine inpatient or outpatient care at participating institutions for local complications of acute pancreatitis or postoperative pancreatic fistula.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Routine Clinical Management of Local Complications
Procedure/SurgeryParticipants receive routine clinical management selected by their treating clinicians. Management may include conservative treatment, endoscopic or percutaneous drainage, necrosectomy, stent placement, or surgery when clinically indicated. No diagnostic or therapeutic procedure is assigned by the study protocol.
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: Patients With Local Complications of Acute Pancreatitis or Postoperative Pancreatic Fistula1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Participants Achieving Clinical Success Within 180 Days
Clinical success is defined as resolution of the symptoms and clinical signs that required treatment, together with resolution or marked reduction of the target fluid collection on follow-up imaging. For infection-related cases, improvement in at least two of body temperature, white blood cell count, and C-reactive protein is required.
Time frame
Within 180 days after enrollmentSecondary outcomes
1
Proportion of Participants With Technical Success of the Initial Intervention
Technical success is defined as successful completion of the intended endoscopic, percutaneous, or surgical procedure. This measure will be assessed only among participants who undergo an intervention.
Time frame
On the day of the initial intervention (1 day per participant)2
Procedure-Related Adverse Events
Proportion of participants experiencing an adverse event considered related to an endoscopic, percutaneous, or surgical procedure.
Time frame
Within 180 days after enrollment3
Need for Additional Intervention
Proportion of participants requiring an additional endoscopic, percutaneous, or surgical intervention for the index local complication.
Time frame
Within 180 days after enrollment4
Recurrence of the Target Fluid Collection
Proportion of participants with recurrence of a symptomatic target fluid collection requiring treatment after initial clinical success.
Time frame
Within 180 days after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tokyo University
Lead sponsor
Tokyo Women's Medical University
Sponsor institution
Source ClinicalTrials.gov