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

NCT ID: NCT07080697

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2028-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Necrotizing Pancreatitis Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group will receive open debridement combined with distal pancreatectomy and total splenectomy, the other group will receive open debridement alone.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Splenectomy group

Open Debridement combined with Distal Pancreatectomy and Total Splenectomy

Group Type EXPERIMENTAL

Splenectomy

Intervention Type PROCEDURE

Open Debridement combined with distal pancreatectomy and total splenectomy

Control group

Open Debridement alone

Group Type EXPERIMENTAL

Control

Intervention Type PROCEDURE

Open Debridement alone

Interventions

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Splenectomy

Open Debridement combined with distal pancreatectomy and total splenectomy

Intervention Type PROCEDURE

Control

Open Debridement alone

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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TingBo Liang

Director physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yun Zhang

Role: CONTACT

086-18058715288

Jian Zhang

Role: CONTACT

086-18758197996

Facility Contacts

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Ting-Bo Liang

Role: primary

086-571-87236688

Other Identifiers

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IIT20250028C

Identifier Type: -

Identifier Source: org_study_id

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