Acute Necrotizing Pancreatitis, Portal Hypertension
Conditions
Keywords
Acute Necrotizing Pancreatitis, Pancreatic Sinistral Portal Hypertension, Debridement, Splenectomy
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.
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
PROCEDURESplenectomy
Open Debridement combined with distal pancreatectomy and total splenectomy
PROCEDUREControl
Open Debridement alone
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One group will receive open debridement combined with distal pancreatectomy and total splenectomy, the other group will receive open debridement alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay after debridement | 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. |
| Degree of pancreatic sinistral portal hypertension | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Perioperative | Abdominal lavage volume after treatment |
| Life quality one year after treatment | 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. |
| Intensive Care Unit stay post Operation | Perioperative | — |
| Pancreatic Fistula | Perioperative | The rate of pancreatic fistula |
Other
| Measure | Time frame |
|---|---|
| Platelet number after debridement | Within one year after the last subject was treated |
Countries
China
Contacts
Primary ContactYun Zhang
Backup ContactJian Zhang
Outcome results
None listed