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Effect of modified treatment strategy for infected necrotizing pancreatitis

Effect of modified treatment strategy for infected necrotizing pancreatitis: A prospective pilot study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077143
Enrollment
Unknown
Registered
2023-10-31
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infected necrotizing pancreatitis

Interventions

Early intervention group:Early open necrosectomy after 30 days from the onset

Sponsors

Jinling Hospital, Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Less than 30 days from onset to admission; 2. Adult patients (18-70 years old); 3. Meet the diagnostic criteria of IPN (at the same time meet the following three) : 1) Meet AP diagnostic criteria (=2 items) : a. Persistent pain in the upper abdomen; b. Serum amylase and/or lipase are 3 times higher than the normal upper limit; c. Typical findings of abdominal imaging (pancreatic edema/necrosis or peripancreatic effusion); 2) Enhanced CT confirmed the presence of parenchymal or peripancreatic necrosis 3) The drainage fluid culture of pancreatic necrotic tissue was positive in etiology; 4. Receive minimally invasive drainage treatment (including percutaneous drainage, endoscopic transgastric or transduodenal papillary drainage, etc.); 5. Early risk of minimally invasive treatment failure: the prediction model calculated that the probability of minimally invasive treatment failure was > 50%; The SOFA score increased by more than 2 points compared with the last minimally invasive drainage or continued organ function did not relieve. 6. Subjects voluntarily participate in the study and have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient had undergone open necrosectomy before admission; 2. Indications for open surgery are clearly present within 30 days of onset (any of the following conditions occur) : 1) Combined with abdominal compartment syndrome, abdominal pressure =30 mmHg(1 mmHg=0.133 kPa) and progressive increase of abdominal pressure after non-surgical treatment; 2) There is active bleeding in IPN, which cannot be stopped after non-surgical treatment and is life-threatening; 3) Digestive tract fistula that cannot be adequately drained; 4) Septic shock progressive aggravation. 3. Patients and their families give up treatment due to economic reasons; 4. Have serious cardiovascular, respiratory, kidney or liver diseases.

Design outcomes

Primary

MeasureTime frame
All-Cause Mortality;

Secondary

MeasureTime frame
Major complication incidence;Total number of days of organ failure;The number of rescue operations and the total number of open operations;Incidence of incisional hernia;Length of stay in ICU and hospital;Total cost in-hospital ;

Countries

China

Contacts

Public ContactWeiqin Li

Jinling Hospital, Nanjing University

ctgchina@medbit.cn+86 139 5183 9654

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026