Dual-scopic Pancreatic Necrosectomy (DPN)

Sponsor

First People's Hospital of Hangzhou (Other)

Overall Status

Recruiting

CT.gov ID

NCT04443595

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatitis Pancreatitis, Acute Necrotizing Pancreatic Diseases	Procedure: Dual-scopic pancreatic necrosectomy（DPN）	N/A

Study Design

Study Type:

Interventional

Anticipated 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)

Anticipated Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

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

Primary Outcome Measures

Complication Rate [through study completion, an average of 24 weeks]
Proportion of patients with perioperative complications
Mortality [through study completion, an average of 24 weeks]
Proportion of patients dying in the perioperative period

Secondary Outcome Measures

Hospital stay [through study completion, an average of 24 weeks]
Length of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hangzhou First People's Hospital	Hangzhou	Zhe Jiang	China	310006

Sponsors and Collaborators

First People's Hospital of Hangzhou

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jun 23, 2020

Last Update Posted:

Jun 23, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatitis

Pancreatic Diseases

Pancreatitis, Acute Necrotizing

Study Results

No Results Posted as of Jun 23, 2020