Surgical procedure for treating severe pancreatitis
Dual-scopic Pancreatic Necrosectomy (DPN): Laparoscopic Pancreatic Necrosectomy (LPN) and Nephroscopic Pancreatic Necrosectomy (NPN)
This study tests a new surgical method for people with severe pancreatitis to see if it can safely remove damaged tissue and help them heal better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First People's Hospital of Hangzhou Academic / other |
| Locations | 1 site (Hangzhou, Zhe Jiang) |
| Trial ID | NCT04443595 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a dual-scopic pancreatic necrosectomy (DPN) procedure for patients suffering from acute necrotizing pancreatitis. The approach involves a combination of laparoscopic and retroperitoneal techniques to access and remove necrotic tissue and pus from the pancreas. Patients undergo general anesthesia, and the procedure includes continuous irrigation of the necrotic cavity post-surgery to promote healing. The study aims to evaluate the effectiveness and safety of this innovative surgical intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with acute pancreatitis meeting specific clinical criteria.
Not a fit: Patients under 18, pregnant women, those with renal dysfunction, severe heart issues, or coagulation disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could significantly improve recovery outcomes for patients with severe pancreatitis.
How similar studies have performed: While similar surgical approaches have been explored, the dual-scopic technique represents a novel intervention that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hangzhou, Zhe Jiang
- Hangzhou First People's Hospital — Hangzhou, Zhe Jiang, China (Recruiting)
Study contacts
- Study coordinator: Yang Cai
- Email: caiyang6969@163.com
- Phone: +8613867136969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.