Dual-scopic Pancreatic Necrosectomy (DPN)

Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04443595
• Other study ID #: 2020-009-1
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2020
• Source: First People's Hospital of Hangzhou
• Contact: Yang Cai
• Phone: +8613867136969
• Email: caiyang6969[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Diseases
• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

Procedure:
• Dual-scopic pancreatic necrosectomy(DPN)
Treatment of Acute Severe Pancreatitis with DPN

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou	Zhe Jiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication Rate	Proportion of patients with perioperative complications	through study completion, an average of 24 weeks
Primary	Mortality	Proportion of patients dying in the perioperative period	through study completion, an average of 24 weeks
Secondary	Hospital stay	Length of hospital stay	through study completion, an average of 24 weeks