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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Open Debridement combined with distal pancreatectomy and total splenectomy
Open Debridement alone
First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGLength of hospital stay after debridement
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)
Degree of pancreatic sinistral portal hypertension
The degree of pancreatic sinistral portal hypertension after intervention
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Intensive Care Unit stay post Operation
Time frame: Perioperative
Pancreatic Fistula
The rate of 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)
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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
Abdominal lavage volume after treatment
Time frame: 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.
Time frame: Within one year after the last subject was treated