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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| Ruijin Hospital |
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The purpose of this study is to compare the clinical efficacy and economic cost of enucleation after placement of pancreatic duct stents before surgery with that of direct enucleation alone, and to evaluate its safety and feasibility.
The research contents of this study include: patients with insulinoma near the main pancreatic duct in the head and neck of the pancreas were randomly divided into two groups: the preoperative pancreatic duct stent enucleation group (stended EN), the direct en group (DEN), the Sen group asked a digestive endoscopist to place the pancreatic duct stent before surgery, and the next day or the next day after surgery, and the den group received enucleation directly. The safety of the two groups was compared, including the evaluation of surgical effect Postoperative complications and long-term prognosis based on follow-up data analysis; At the same time, the differences between the two groups were evaluated from the perspective of health economics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stented EN | Experimental | Patients are placed the pancreatic duct stent by endoscopist 1day or several hours before the enucleation surgery. |
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| Direct EN | Active Comparator | Patients will receive enucleation surgery directly following normal procedure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placement of pancreatic duct stents before enucleation surgery | Procedure | Advance placement of pancreatic stents endoscopically |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of POPF within 3 months after EN. | Postoperative clinically relevant pancreatic fistula in this study adopts the definition proposed by the international pancreatic surgery research group (ISGPS) | 3 days to 3 months after enucleation (or the extubation time),up to 6 month after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of postoperative abdominal infection within 3 weeks after EN | Abdominal infection can be basically diagnosed if one of the following conditions occurs:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Xu, Doctor | Contact | +86-13810096103 | xuqiang@pumch.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38569703 | Derived | Gao R, Yin B, Jin J, Tian X, Zhang Y, Wei J, Cao F, Wang Z, Ma Z, Wang M, Gou S, Cong L, Xu Q, Wu W, Zhao Y. Preoperative pancreatic stent placement before the enucleation of insulinoma located in the head and neck of the pancreas in proximity to the main pancreatic duct: study protocol for a multicentre randomised clinical trial in Chinese tertiary medical centres. BMJ Open. 2024 Apr 2;14(4):e078516. doi: 10.1136/bmjopen-2023-078516. |
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Data obtained through this study may be provided to qualified researchers with academic interest in the surgical treatment of insulinoma. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis."Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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| OTHER |
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Outcome assessors are kept blinded to participant group allocation. Objective clinical data are provided to independent assessors with blindness of allocation. With clear definition for each endpoints, assessors are able to make grading for complications in primary and secondary endpoints
| Direct enucleation surgery | Procedure | Patients will receive direct enucleation surgery |
|
| 3 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion |
| Rate of postoperative delayed gastric emptying within 3 weeks after EN | Gastric emptying disorder can be diagnosed if the solid diet cannot be restored 1 week after operation and the gastric tube cannot be removed. | 3 days to 3 weeks after enucleation (or the extubation time) |
| Rate of postoperative hemorrhagepostpancreatectomy haemorrhage within 3 weeks after EN | Postoperative hemorrhage refers to the occurrence of bloody fluid in the abdominal drainage tube or gastrointestinal decompression tube, which can also be manifested as blood in the stool, accompanied by changes in vital signs such as heart rate and blood pressure, as well as a decrease in hemoglobin concentration. | 1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion |
| Rate of postoperative dyspepsia within 6 months after EN | According to Rome IV standard, the diagnosis should meet the following requirements: Symptoms appear for at least 2 months, and must include one or more of the following uncomfortable symptoms, and at least 4 times a month: a. fullness after meals; b. Early satiety; c. Epigastric pain or burning sensation has nothing to do with defecation; d. After proper evaluation, the symptoms cannot be completely explained by other disease conditions. | 2 weeks to 6 months after enucleation,,up to 6 month after inclusion |
| Rate of postoperative lung infection within 3 weeks after EN | Patients with any of the following conditions: a. continuous fever or leukocytosis, accompanied by postoperative chest X-ray or chest CT positive findings (consolidation of lung, pneumonia, atelectasis, with or without pleural effusion), and decreased body temperature after antibiotics; b. Sputum culture is positive, accompanied by continuous fever or leukocyte elevation, and body temperature drops after antibiotics; c. Pleural effusion affects the patient's breathing and requires pleural puncture and drainage. | 1 days to 3 weeks after enucleation (or the extubation time),,up to 6 month after inclusion |
| Rate of postoperative hyperglycemia within 6 months after EN | the diagnosis should meet at least one of the following requirements: a. hemoglobin A1c (HbA1c) value ≥ 6.5%; b. If the fasting blood glucose is ≥ 126mg / dl, the test should be repeated on another day. Fasting is defined as at least 8 hours without calorie intake; c. Oral glucose tolerance test (OGTT), plasma glucose ≥ 200 mg / dl at 2 hours after 75g (100g for pregnant women) glucose load; d. Hyperglycemic symptoms and accidental (random) plasma glucose ≥ 200mg / dl. | 2 weeks to 6 months after enucleation,,up to 6 month after inclusion |
| Rate of post-stent-placement acute pancreatitis in Stented EN group within in 3 weeks after EN | Patients with any two of the following three criteria can be diagnosed : a. abdominal pain consistent with the onset; b. Biochemical evidence of pancreatitis (serum amylase and / or lipase greater than 3 times the upper limit of normal); c. Typical manifestations of abdominal image (pancreatic edema / necrosis or exudation and effusion around the pancreas) | 1 days to 3 days after stent placement,,up to 6 month after inclusion |
| Operation time | Measure during operation,,up to 6 month after inclusion |
| Intraoperative blood loss | Measure during operation,,up to 6 month after inclusion |
| Total cost of hospitalization | Measure during the whole hospitalization procedure of each patient,,up to 6 month after inclusion |
| ID | Term |
|---|---|
| D007340 | Insulinoma |
| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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