First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Location status: Recruiting
NCT Number: NCT07080697
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.
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Request Info18 year–75 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310003, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Open Debridement combined with distal pancreatectomy and total splenectomy
Open Debridement alone
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
The total length of hospital stay after debridement, including readmissions.
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
The degree of pancreatic sinistral portal hypertension after intervention
Time frame: Perioperative
Time frame: Perioperative
The rate of pancreatic fistula
Time frame: Perioperative
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Time frame: Perioperative
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Time frame: Perioperative
Time frame: Perioperative
Abdominal lavage volume after treatment
Time frame: Within one year after the last subject was treated
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.
Time frame: Within one year after the last subject was treated
Contact information is provided by the study sponsor or research team.
Jian Zhang
CONTACT
Yun Zhang
CONTACT
Zhejiang University
Other
The Impact of Splenectomy on Debridement Efficacy, Perioperative Recovery, and Prognosis in Patients With Acute Necrotizing Pancreatitis Complicated by Pancreatic Sinistral Portal Hypertension
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