Dual-scopic Pancreatic Necrosectomy (DPN)

Dual-scopic Pancreatic Necrosectomy (DPN): Laparoscopic Pancreatic Necrosectomy (LPN) and Nephroscopic Pancreatic Necrosectomy (NPN)

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Diseases; Pancreatitis; Pancreatitis, Acute Necrotizing
• Intervention / Treatment: Procedure: Dual-scopic pancreatic necrosectomy（DPN）

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Cai; Phone Number: +8613867136969; Email: caiyang6969@163.com

Study Locations

• China
  • Zhe Jiang
    • Hangzhou, Zhe Jiang, China, 310006
      • Recruiting
      • Hangzhou First People's Hospital
      • Contact: Yang Cai; Phone Number: +8613867136969; Email: caiyang6969@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	Length of hospital stay	through study completion, an average of 24 weeks

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatitis; Pancreatic Diseases; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: 2020-009-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No