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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Splenectomy group | Experimental | Open Debridement combined with Distal Pancreatectomy and Total Splenectomy |
|
| Control group | Experimental | Open Debridement alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Splenectomy | Procedure | Open Debridement combined with distal pancreatectomy and total splenectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care Unit stay post Operation | Perioperative | |
| Pancreatic Fistula | The rate of pancreatic fistula | Perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet number after debridement | Within one year after the last subject was treated |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Zhang | Contact | 086-18058715288 | bigzyun1977@zju.edu.cn | |
| Jian Zhang | Contact | 086-18758197996 | johnzhang@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D019283 | Pancreatitis, Acute Necrotizing |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D013156 | Splenectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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One group will receive open debridement combined with distal pancreatectomy and total splenectomy, the other group will receive open debridement alone.
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| Control | Procedure | Open Debridement alone |
|
| 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 | Abdominal lavage volume after treatment | 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. | Within one year after the last subject was treated |