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

Zhejiang University

Status: Enrolling

Conditions: Portal Hypertension; Acute Necrotizing Pancreatitis

Treatments: Procedure: Splenectomy; Procedure: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT07080697

IIT20250028C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Splenectomy group

Experimental group

Description:

Open Debridement combined with Distal Pancreatectomy and Total Splenectomy

Treatment:

Procedure: Splenectomy

Control group

Experimental group

Description:

Open Debridement alone

Treatment:

Procedure: Control