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

The Impact of Splenectomy on Debridement Efficacy, Perioperative Recovery, and Prognosis in Patients With Acute Necrotizing Pancreatitis Complicated by Pancreatic Sinistral Portal Hypertension

This trial will test whether removing the spleen during open debridement helps adults with acute necrotizing pancreatitis and left-sided (sinistral) portal hypertension recover faster and with fewer complications than debridement alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07080697 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with acute necrotic pancreatitis complicated by pancreatic sinistral portal hypertension who require open debridement for infected pancreatic necrosis are the ideal candidates.

Not a fit: Patients with pre-existing organ failure, cirrhosis or other causes of portal hypertension, hematologic disorders, or those treated with laparoscopic/nephroscopic debridement are excluded and unlikely to benefit from the studied approach.

Why it matters

Potential benefit: If successful, adding splenectomy could shorten hospital stays, reduce portal-hypertension–related problems, and improve recovery and quality of life for this subgroup of patients.

How similar studies have performed: While splenectomy is an established surgical option for left-sided portal hypertension in other settings, randomized evidence for adding splenectomy in acute necrotizing pancreatitis with PSPH is limited, making this a relatively novel randomized comparison.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang

• First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Yun Zhang

Conditions: Acute Necrotizing Pancreatitis, Portal Hypertension, Pancreatic Sinistral Portal Hypertension, Debridement, Splenectomy