Dual-scopic Pancreatic Necrosectomy (DPN)

NCT ID: NCT04443595

Last Updated: 2020-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatitis Pancreatitis, Acute Necrotizing Pancreatic Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Treatment of Acute Severe Pancreatitis with DPN

Group Type EXPERIMENTAL

Dual-scopic pancreatic necrosectomy(DPN)

Intervention Type PROCEDURE

Treatment of Acute Severe Pancreatitis with DPN

Interventions

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Dual-scopic pancreatic necrosectomy(DPN)

Treatment of Acute Severe Pancreatitis with DPN

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First People's Hospital of Hangzhou

OTHER

Sponsor Role lead

Responsible Party

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Yang Cai

Director, Deputy Chief of Hepatobiliary and Pancreatic Surgery, Professor.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Cai

Role: CONTACT

+8613867136969

Facility Contacts

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Yang Cai

Role: primary

+8613867136969

Other Identifiers

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2020-009-1

Identifier Type: -

Identifier Source: org_study_id

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