A Study to Evaluate Splenectomy on Debridement for Acute Necrotizing Pancreatitis With Pancreatic Sinistral Portal Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Splenectomy, Control.
- Who it may be relevant to
- Registry conditions: Acute Necrotizing Pancreatitis, Portal Hypertension. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Splenectomy on Debridement Efficacy, Perioperative Recovery, and Prognosis in Patients With Acute Necrotizing Pancreatitis Complicated by Pancreatic Sinistral Portal Hypertension
Overview
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.
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.
Interventions
- Procedure Splenectomy
Open Debridement combined with distal pancreatectomy and total splenectomy - Procedure Control
Open Debridement alone
Primary outcome measures
- Length of hospital stay after debridement [Time frame: 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 [Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)]
Secondary outcome measures (11)
- Intensive Care Unit stay post Operation [Time frame: Perioperative]
- Pancreatic Fistula [Time frame: Perioperative]
- Number of Draining Tube when Discharged [Time frame: Perioperative]
- 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)]
- Cost post debridement in the first hospitalization [Time frame: Perioperative]
- Number of unplanned re-admissions [Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)]
- Number of unplanned operations [Time frame: 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 [Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)]
- Antibiotic use after treatment [Time frame: Perioperative]
- Abdominal lavage [Time frame: Perioperative]
- Life quality one year after treatment [Time frame: Within one year after the last subject was treated]
Eligibility criteria
Inclusion criteria
- Age between 18 and 75 years.
- Acute necrotic pancreatitis complicated by pancreatic sinistral portal hypertension.
- Patients undergoing open debridement for infected pancreatic necrosis
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07080697 · IIT20250028C