Actively Recruiting
The Impact of Splenectomy on Debridement Efficacy, Perioperative Recovery, and Prognosis in Patients With Acute Necrotizing Pancreatitis Complicated by Pancreatic Sinistral Portal Hypertension
Led by Zhejiang University · Updated on 2025-07-23
66
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, single-center, randomized controlled trial to study patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). The trial aims to evaluate how total splenectomy affects the effectiveness of debridement surgery, recovery during the perioperative period, and the overall prognosis for these patients. This study plans to enroll 66 participants and compares two surgical approaches to better understand their impacts on patient outcomes. Participants will be randomly assigned to one of two groups: one receiving open debridement combined with distal pancreatectomy and total splenectomy, and the other receiving open debridement alone. The study will observe differences in recovery and prognosis between these two surgical methods, focusing on hospital stay length, treatment costs, life quality after surgery, and improvement in PSPH. Secondary outcomes include monitoring infection control, antibiotic use, drainage management, platelet count changes, and the frequency of additional operations or readmissions. During the study, participants will be closely monitored from enrollment until up to five years after surgery. Researchers will track hospital stay durations, intensive care unit time, and complications like pancreatic fistula. Life quality will also be assessed up to one year after treatment. Data on postoperative costs, drainage tube removal, antibiotic use, and abdominal lavage will be collected to evaluate surgical recovery. This comprehensive follow-up will help assess the overall impact of the surgical options on patient health and recovery.
CONDITIONS
Brief Title
A Study to Evaluate Splenectomy on Debridement for Acute Necrotizing Pancreatitis With Pancreatic Sinistral Portal Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosis of acute necrotic pancreatitis complicated by pancreatic sinistral portal hypertension
- Patients undergoing open debridement for infected pancreatic necrosis
You will not qualify if you...
- Pre-existing heart, lung, liver, kidney, or other organ failure prior to acute pancreatitis
- Pre-existing conditions such as cirrhosis leading to portal hypertension before acute pancreatitis
- Pre-existing hematological diseases prior to acute pancreatitis
- Patients undergoing laparoscopic or nephroscopic debridement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Perioperative period
Participants undergo open debridement surgery with or without distal pancreatectomy and total splenectomy, followed by immediate post-operative care to support recovery.
Hospital stay with monitoring during surgery and immediate recovery
Duration - Up to 5 years
Participants are followed to assess recovery, complications, and long-term outcomes including life quality and portal hypertension alleviation.
Regular follow-up visits over the course of up to 5 years
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
Y
Yun Zhang
J
Jian Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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