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

ConditionsAcute Necrotizing PancreatitisPortal Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 75 years.

Acute necrotic pancreatitis complicated by pancreatic sinistral portal hypertension.

Patients undergoing open debridement for infected pancreatic necrosis

Disqualifiers

Patients with pre-existing heart, lung, liver, kidney, or other organ failure prior to acute pancreatitis (AP).

Patients with pre-existing conditions such as cirrhosis that may lead to portal hypertension prior to AP.

Patients with pre-existing hematological diseases prior to AP.

Patients undergoing laparoscopic or nephroscopic debridement.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Splenectomy

    Procedure/Surgery

    Open Debridement combined with distal pancreatectomy and total splenectomy

  • Control

    Procedure/Surgery

    Open Debridement alone

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Splenectomy groupExperimental treatment 1 intervention
Group B: Control groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Length of hospital stay after debridement

The total length of hospital stay after debridement, including readmissions.

Time frame
From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
2

Degree of pancreatic sinistral portal hypertension

The degree of pancreatic sinistral portal hypertension after intervention

Time frame
From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)

Secondary outcomes

1

Intensive Care Unit stay post Operation

Time frame
Perioperative
2

Pancreatic Fistula

The rate of pancreatic fistula

Time frame
Perioperative
3

Number of Draining Tube when Discharged

Time frame
Perioperative
4

Time of all draining tubes removal

Time frame
From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)

Other outcomes

1

Platelet number after debridement

Time frame
Within one year after the last subject was treated

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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