Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07080697

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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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