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

NCT07080697 | Recruiting

• 1 other identifier: IIT20250028C
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Necrotizing Pancreatitis; Portal Hypertension

Keywords

Acute Necrotizing Pancreatitis; Pancreatic Sinistral Portal Hypertension; Debridement; Splenectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Intensive Care Unit stay post Operation

  Perioperative

• 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

Other Outcomes (1)

• Platelet number after debridement

  Within one year after the last subject was treated

Study Arms (2)

Splenectomy group

EXPERIMENTAL

Open Debridement combined with Distal Pancreatectomy and Total Splenectomy

Procedure: Splenectomy

Control group

EXPERIMENTAL

Open Debridement alone

Procedure: Control

Interventions

Splenectomy PROCEDURE

Open Debridement combined with distal pancreatectomy and total splenectomy

Splenectomy group

Control PROCEDURE

Open Debridement alone

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years.
• Acute necrotic pancreatitis complicated by pancreatic sinistral portal hypertension.
• Patients undergoing open debridement for infected pancreatic necrosis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Hypertension, Portal

Interventions

Splenectomy

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Yun Zhang

CONTACT

086-18058715288; bigzyun1977@zju.edu.cn

Jian Zhang

CONTACT

086-18758197996; johnzhang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director physician

Model Details: One group will receive open debridement combined with distal pancreatectomy and total splenectomy, the other group will receive open debridement alone.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 23, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)