A Multi-center Study to Evaluate the Efficacy and Safety of Pancreatic Duct Stents Placement Before the Enucleation of Insulinoma Located in the Head and Neck of the Pancreas Near the Main Pancreatic Duct

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-center Study to Evaluate the Efficacy and Safety of Pancreatic Duct Stents Placement Before the Enucleation of Insulinoma Located in the Head and Neck of the Pancreas Near the Main Pancreatic Duct

Conditions
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Insulinoma

Intervention / Treatment
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* Procedure: placement of pancreatic duct stents before enucleation surgery
* Procedure: Direct enucleation surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The clinical qualitative diagnosis of insulinoma was clear; The localization diagnosis was clear, and it was determined that the tumor was single, located in the head and neck; The distance between the tumor and the main pancreatic duct was determined to be ≤ 2mm by preoperative imaging (enhanced CT, MRI, etc.); Truly informed and voluntarily participate in this study. Exclusion Criteria: Maximum diameter of the tumor >2cm proved pathologically Severe cardiopulmonary complications before operation Combined with other known tumor diseases Insulinoma is invasive or has suspicious metastatic lesions Previous upper abdominal surgery history Refusal or inability to cooperate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stented EN<br>Patients are placed the pancreatic duct stent by endoscopist 1day or several hours before the enucleation surgery. | Procedure: placement of pancreatic duct stents before enucleation surgery<br>* Advance placement of pancreatic stents endoscopically<br>|
| Active Comparator: Direct EN<br>Patients will receive enucleation surgery directly following normal procedure | Procedure: Direct enucleation surgery<br>* Patients will receive direct enucleation surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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: After 3 days of operation, the patient developed chills, high fever, abdominal distension, intestinal paralysis, etc., which lasted for more than 24 hours. The laboratory examination results showed that the leukocyte count increased significantly, with or without hypoproteinemia and anemia, and the imaging images showed the accumulation of fluid in the abdominal cavity; The aspiration fluid was purulent or bacteria were detected in the fluid; The infection was localized and formed inclusion. In imaging, fluid accumulation foci with clear edges and with or without gas could be seen. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic enucleation, Pancreatic duct stent, Regular pancreatectomy, Health economics evaluation