NCT04494282

Brief Summary

Pancreatic pseudocysts (PP) present as a complication that occurs in 5-15% of acute pancreatitis and 26-40% of chronic pancreatitis (1-3). To date the endoscopic drainage with endoscopic ultrasound (EUS) has replace the surgical treatment due to the similar success and complication rate but with a lower cost and short hospital stay (4-6). Regarding recurrence, it is important to know the anatomy of the main pancreatic duct (MPD). For this purpose, the endoscopic retrograde pancreatography (ERP) has been describe as a useful tool. In fact, many authors perform it before the endoscopic drainage while others wait several weeks after the drainage (7-9) with similar technical success (5,8). However, there are no studies that compare the technical difficulty and the total cost between these two approaches.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

4.8 years

First QC Date

July 28, 2020

Last Update Submit

March 4, 2024

Conditions

Keywords

Pancreatic Pseudocyst

Outcome Measures

Primary Outcomes (1)

  • The impact of the pancreatography in the endoscopic treatment of pancreatic pseudocysts

    Determine the impact of the timing performing an endoscopic pancreatography in relation of the drainage of pancreatic pseudocyst

    6 weeks

Study Arms (2)

Same day

ACTIVE COMPARATOR

The ERP will be performed the same day of the endoscopic drainage of PP

Procedure: Endoscopic retrograde pancreatography

Other day

ACTIVE COMPARATOR

The ERP will be performed 6 weeks after the endoscopic drainage of PP.

Procedure: Endoscopic retrograde pancreatography

Interventions

Endoscopic cannulation of main pancreatic duct

Other daySame day

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pancreatic pseudocyst that fulfilled the Atlanta Classification
  • Symptomatic pancreatic pseudocyst
  • Informed consent obtained

You may not qualify if:

  • Patient unwilling to participate
  • Absence of duration time of the pancreatography procedure in the record
  • Absence of the number of weeks between the drainage and the pancreatography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Pseudocyst

Condition Hierarchy (Ancestors)

Pancreatic CystCystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Random control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 31, 2020

Study Start

August 1, 2015

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

March 6, 2024

Record last verified: 2024-03