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

Study Overview

• Status: Recruiting
• Conditions: Portal Hypertension; Acute Necrotizing Pancreatitis
• Intervention / Treatment: Procedure: Splenectomy; Procedure: Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yun Zhang; Phone Number: 086-18058715288; Email: bigzyun1977@zju.edu.cn
• Study Contact Backup: Name: Jian Zhang; Phone Number: 086-18758197996; Email: johnzhang@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Ting-Bo Liang; Phone Number: 086-571-87236688; Email: liangtingbo@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Splenectomy group; Open Debridement combined with Distal Pancreatectomy and Total Splenectomy	Procedure: Splenectomy; Open Debridement combined with distal pancreatectomy and total splenectomy
Experimental: Control group; Open Debridement alone	Procedure: Control; Open Debridement alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay after debridement	The total length of hospital stay after debridement, including readmissions.	From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Degree of pancreatic sinistral portal hypertension	The degree of pancreatic sinistral portal hypertension after intervention	From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive Care Unit stay post Operation		Perioperative
Pancreatic Fistula	The rate of pancreatic fistula	Perioperative
Number of Draining Tube when Discharged		Perioperative
Time of all draining tubes removal		From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Cost post debridement in the first hospitalization		Perioperative
Number of unplanned re-admissions		From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Number of unplanned operations		From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Number of percutaneous drainage after debridement		From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Antibiotic use after treatment		Perioperative
Abdominal lavage	Abdominal lavage volume after treatment	Perioperative
Life quality one year after treatment	Life quality one year after treatment was judged by the Short-Form 36 Health Survey (SF-36), encompassing both physical and mental health across eight dimensions: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The minimum value is 0%, the maximum value is 100%, and a higher score means a better life quality.	Within one year after the last subject was treated

Other Outcome Measures

Outcome Measure	Time Frame
Platelet number after debridement	Within one year after the last subject was treated

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 29, 2028

Study Registration Dates

• First Submitted: July 4, 2025
• First Submitted That Met QC Criteria: July 20, 2025
• First Posted (Actual): July 23, 2025

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 20, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Debridement; Splenectomy; Acute Necrotizing Pancreatitis; Pancreatic Sinistral Portal Hypertension
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Digestive System Diseases; Pancreatic Diseases; Liver Diseases; Hypertension; Pancreatitis; Hypertension, Portal; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: IIT20250028C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No