Dual-scopic Pancreatic Necrosectomy (DPN)
1 other identifier
interventional
20
1 country
1
Brief Summary
The LPN procedure is performed under general anesthesia. The transperitoneal access to peripancreatic space is via the gastro-colic ligament and greater omentum, effusion and pus is removed by laparoscopic forceps and suction. Laparoscopic cholecystectomy (LC) is performed during the LPN procedure on patients with indication. The NPN procedure is followed by the standard retroperitoneal approach. After the catheter is exchanged over a guide wire and serially dilated up from 6F to 24F followed by Seldinger technique, the access track to the necrotic cavity is established. A nephroscope is inserted into the cavity through the track for debridement. Using forceps and suction, the peripancreatic solid necrotic tissue and pus is grasped and removed. A large-bore irrigating drain is left in the cavity, with continuous irrigation by warm normal saline solution at a rate of 100-125 ml/h after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2020
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
June 17, 2020
CompletedFirst Posted
Study publicly available on registry
June 23, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 23, 2020
June 1, 2020
5.5 years
June 17, 2020
June 22, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Complication Rate
Proportion of patients with perioperative complications
through study completion, an average of 24 weeks
Mortality
Proportion of patients dying in the perioperative period
through study completion, an average of 24 weeks
Secondary Outcomes (1)
Hospital stay
through study completion, an average of 24 weeks
Study Arms (1)
Experimental
EXPERIMENTALTreatment of Acute Severe Pancreatitis with DPN
Interventions
Treatment of Acute Severe Pancreatitis with DPN
Eligibility Criteria
You may qualify if:
- All patients ages 18 or above admitted to UPMC with a diagnosis of AP based on at least 2 of the following criteria:(i) abdominal pain characteristic of AP (ii) serum amylase and/or lipase ≥ 3 times the upper limit of normal (iii) characteristic findings of AP on abdominal CT scan will be screened for study enrollment.
You may not qualify if:
- Less than 18 years of age
- Pregnant women
- Presence of renal dysfunction (Cr\>1.5mg/dL)
- Pre existing heart dysfunction or NYHA classification score above III
- Coagulation disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Deputy Chief of Hepatobiliary and Pancreatic Surgery, Professor.
Study Record Dates
First Submitted
June 17, 2020
First Posted
June 23, 2020
Study Start
July 1, 2020
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
June 23, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share