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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04443595
Other study ID # 2020-009-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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