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A Study to Evaluate Splenectomy on Debridement for Acute Necrotizing Pancreatitis With Pancreatic Sinistral Portal Hypertension

A Study to Evaluate Splenectomy on Debridement for Acute Necrotizing Pancreatitis With Pancreatic Sinistral Portal Hypertension

Recruiting
18-75 years
All
Phase N/A

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Overview

This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). The study aims to study the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH.

Description

This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). A total of 66 participants are planned to be enrolled. The study aims to compare the outcomes of two surgical approaches: open debridement combined with distal pancreatectomy and total splenectomy versus open debridementalone. The objective is to observe the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH. The primary observational indicators include postoperative length of hospital stay, postoperative cost, postoperative life quality, and the alleviation of PSPH. Secondary observational indicators encompass the number of unplanned reoperations, postoperative infection control, postoperative irrigation volume, postoperative antibiotic consumption, and postoperative platelet count change. The study will be carried out in accordance with the protocol.

Eligibility

Inclusion Criteria:

  1. Age between 18 and 75 years.
  2. Acute necrotic pancreatitis complicated by pancreatic sinistral portal hypertension.
  3. Patients undergoing open debridement for infected pancreatic necrosis

Exclusion Criteria:

  1. Patients with pre-existing heart, lung, liver, kidney, or other organ failure prior to acute pancreatitis (AP).
  2. Patients with pre-existing conditions such as cirrhosis that may lead to portal hypertension prior to AP.
  3. Patients with pre-existing hematological diseases prior to AP.
  4. Patients undergoing laparoscopic or nephroscopic debridement.

Study details
    Acute Necrotizing Pancreatitis
    Portal Hypertension

NCT07080697

Zhejiang University

15 October 2025

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