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Dual-scopic Pancreatic Necrosectomy (DPN)

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ClinicalTrials.gov Identifier: NCT04443595
Recruitment Status : Recruiting
First Posted : June 23, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Yang Cai, First People's Hospital of Hangzhou

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pancreatitis Pancreatitis, Acute Necrotizing Pancreatic Diseases Procedure: Dual-scopic pancreatic necrosectomy（DPN） Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dual-scopic Pancreatic Necrosectomy (DPN): Laparoscopic Pancreatic Necrosectomy (LPN) and Nephroscopic Pancreatic Necrosectomy (NPN)
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
Treatment of Acute Severe Pancreatitis with DPN
 Procedure: Dual-scopic pancreatic necrosectomy（DPN）
Treatment of Acute Severe Pancreatitis with DPN


Outcome Measures
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Primary Outcome Measures :
  1. Complication Rate [ Time Frame: through study completion, an average of 24 weeks ]
    Proportion of patients with perioperative complications

  2. Mortality [ Time Frame: through study completion, an average of 24 weeks ]
    Proportion of patients dying in the perioperative period


Secondary Outcome Measures :
  1. Hospital stay [ Time Frame: through study completion, an average of 24 weeks ]
    Length of hospital stay


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04443595


Contacts
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Contact: Yang Cai +8613867136969 caiyang6969@163.com

Locations
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China, Zhe Jiang
Hangzhou First People's Hospital Recruiting
Hangzhou, Zhe Jiang, China, 310006
Contact: Yang Cai    +8613867136969    caiyang6969@163.com   
Sponsors and Collaborators
First People's Hospital of Hangzhou
More Information
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Responsible Party: Yang Cai, Director, Deputy Chief of Hepatobiliary and Pancreatic Surgery, Professor., First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier: NCT04443595    
Other Study ID Numbers: 2020-009-1
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Pancreatitis, Acute Necrotizing
Digestive System Diseases