Dual-scopic Pancreatic Necrosectomy (DPN)
Primary Purpose
Pancreatitis, Pancreatitis, Acute Necrotizing, Pancreatic Diseases
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dual-scopic pancreatic necrosectomy(DPN)
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Hangzhou First People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Treatment of Acute Severe Pancreatitis with DPN
Outcomes
Primary Outcome Measures
Complication Rate
Proportion of patients with perioperative complications
Mortality
Proportion of patients dying in the perioperative period
Secondary Outcome Measures
Hospital stay
Length of hospital stay
Full Information
NCT ID
NCT04443595
First Posted
June 17, 2020
Last Updated
June 22, 2020
Sponsor
First People's Hospital of Hangzhou
1. Study Identification
Unique Protocol Identification Number
NCT04443595
Brief Title
Dual-scopic Pancreatic Necrosectomy (DPN)
Official Title
Dual-scopic Pancreatic Necrosectomy (DPN): Laparoscopic Pancreatic Necrosectomy (LPN) and Nephroscopic Pancreatic Necrosectomy (NPN)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Hangzhou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Pancreatitis, Acute Necrotizing, Pancreatic Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Treatment of Acute Severe Pancreatitis with DPN
Intervention Type
Procedure
Intervention Name(s)
Dual-scopic pancreatic necrosectomy(DPN)
Intervention Description
Treatment of Acute Severe Pancreatitis with DPN
Primary Outcome Measure Information:
Title
Complication Rate
Description
Proportion of patients with perioperative complications
Time Frame
through study completion, an average of 24 weeks
Title
Mortality
Description
Proportion of patients dying in the perioperative period
Time Frame
through study completion, an average of 24 weeks
Secondary Outcome Measure Information:
Title
Hospital stay
Description
Length of hospital stay
Time Frame
through study completion, an average of 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Cai
Phone
+8613867136969
Email
caiyang6969@163.com
Facility Information:
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhe Jiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Cai
Phone
+8613867136969
Email
caiyang6969@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dual-scopic Pancreatic Necrosectomy (DPN)
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