A Novel Surgical Strategy to Reduce Major Complications in Patients With Necrotizing Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

A Novel Surgical Strategy to Reduce Major Complications in Patients With Necrotizing Pancreatitis: A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06241586
• Other study ID #: TianjinNH
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2024
• Source: Tianjin Nankai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to compare patient outcomes between the groups of patients admitted before and after the full implementation of the novel surgical strategy in patients with necrotizing pancreatitis. The main question it aims to answer are:

• the efficacy and safety of the novel surgical strategy To assess the efficacy and safety of the novel surgical strategy, all included patients were divided into two groups according to the timing of receiving treatment: 1) the early period group: patients admitted before January 2021 received the hybrid strategy of traditional and novel surgical strategies; and 2) the late period group: patients admitted during and after January 2021 received the complete novel surgical strategy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: October 1, 2022
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Consecutive patients older than 18 years with necrotizing pancreatitis were included.

Exclusion Criteria:

Patients who met one or more of the following criteria were excluded: (1) had a past medical history of acute pancreatitis; (2) had drainage or surgery for pancreatic necrosis in other hospitals before admission to our institute; and (3) did not complete the treatment strategy owing to nonmedical reasons.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

Procedure:
• The novel PMMI surgical strategy
Immediate drainagewas advocated within 24 hours once necrosis was diagnosed. During the treatment course, a hybrid approach was available by flexibly switching interventions. Open surgery was only applied when patients required emergency surgery. The minimally invasive surgery was selected based on the size, location, and maturity of the necrotic area and stepwise response to intervention. Repeated peritoneal purification was performed until the infected or devitalized tissue was controlled. Patients were subsequently discharged with a drainage catheter and readmitted at 7- to 10-day intervals to receive repeated planned surgery without postoperative irrigation. Patients received a whole-course assessment for individual patients at 7-day predetermined intervals.
• The conventional step-up strategy
Interventions were postponed until 4 weeks after the onset of pancreatitis in line with international guidelines unless the patient showed evidence of progressive clinical deterioration despite the use of maximal supportive care. Patients underwent CT-guided percutaneous catheter drainage as the first step. Treatment response was evaluated after 3 days. If drainage was clinically unsuccessful, a VARD procedure was performed. Similarly, open surgery, which was described by Beger et al., was performed if the VARD procedure failed. Postoperative continuous lavage is performed as a routine procedure.

Locations

Country	Name	City	State
China	Tianjin NanKai Hospital	Tianjin	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Nankai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major complications		90-day follow up
Secondary	mortality		90-day follow up
Secondary	Admission of ICU		up to 90-days
Secondary	Length of hospital stay		up to 90-days
Secondary	individual major complications	The overall complications included procedure-related complications (intra-abdominal and gastrointestinal bleeding, pancreatic fistulas, and gastrointestinal perforation) and nonspecific complications (systemic inflammatory response syndrome, abdominal compartment syndrome, and new-onset renal, respiratory and circulatory failure).	90-day follow up