Removing the spleen with open debridement for necrotizing pancreatitis and left-sided portal hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, randomized controlled trial enrolling 66 adults with infected acute necrotic pancreatitis complicated by pancreatic sinistral portal hypertension. Participants are randomized to open debridement plus distal pancreatectomy and total splenectomy versus open debridement alone. Primary outcomes include postoperative length of hospital stay, cost, patient-reported quality of life, and improvement in portal hypertension; secondary outcomes include unplanned reoperations, infection control, irrigation volume, antibiotic use, and platelet count changes. Key eligibility criteria are age 18–75, infected pancreatic necrosis requiring open debridement, and exclusion of patients with pre-existing organ failure, cirrhosis, hematologic disease, or those undergoing minimally invasive debridement.

Why it matters

Who can join: the full rules

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.

Where it's running

• First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Yun Zhang
• Email: bigzyun1977@zju.edu.cn
• Phone: 086-18058715288

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.