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Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Conventionally, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail. In the ear of minimally invasive pancreatic surgery, when compared with open surgery, laparoscopic technology or Da Vinci robotic technology can avoid some open procedures limitations.
Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures.
Background: Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. Its heterogeneity is large, which can be benign, borderline, and poor differentiation and even evolve into pancreatic cancer. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Some patients may be accompanied by recurrent pancreatitis, abdominal pain, nausea, vomiting, jaundice, and other gastrointestinal symptoms, usually with the help of abdominal ultrasound and endoscopy, ERCP, CT, nuclear magnetic, or MRCP imaging The examination can diagnose the disease. For PCN patients with large tumors, risk of malignant transformation, and accompanying symptoms that affect the quality of life, surgery is an effective treatment.
Based on the conventional routine treatment, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail.
After more than 20 years of development, minimally invasive pancreatic surgery technology can be divided into two categories: laparoscopic technology and Da Vinci robotic technology. In general, compared with open surgery, minimally invasive pancreatic surgery technology can avoid some open procedures limitations, reduce the loss of intraoperative body fluid and its impact on the internal environment, and avoid excessive disturbance to other abdominal organs. It also helps reduce the pain of patients and shorten the length of hospital stay. Because most PCNs are benign or borderline tumors, such patients are eligible for minimally invasive pancreatic surgery.
Aim and Hypothesis: Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures. We conduct a single-center prospective randomized clinical trial to compare the outcomes of different minimally invasive techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIPD-ROB | Experimental | Patients with PCN locates HEAD and NECK of pancreas who were randomized to ROBOTIC pancreaticoduodenectomy. |
|
| MIPD-LAP | Active Comparator | Patients with PCN locates HEAD and NECK of pancreas who were randomized to LAPAROSCOPIC pancreaticoduodenectomy. |
|
| MIDP-ROB | Experimental | Patients with PCN locates BODY and TAIL of pancreas who were randomized to ROBOTIC distal pancreatectomy. |
|
| MIDP-LAP | Active Comparator | Patients with PCN locates BODY and TAIL of pancreas who were randomized to LAPAROSCOPIC distal pancreatectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic pancreaticoduodenectomy | Procedure | The Intervention of MIPD-ROB group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate | The rate of frequency of Clavein-Dindo Grade II-IV complication | up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative length of stay | The mean of postoperative length of stay | during the treatment |
| VAS score | patients complain of pain after surgery, 0-10, 10 means the greatest pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanyu Zhang, M.D. | Contact | 01069152600 | medzhy5813@126.com |
| Name | Affiliation | Role |
|---|---|---|
| MENGHUA Dai, M.D. | Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China | Recruiting | Beijing | 100730 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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The enrolled candidates will be split into two subgroups(PD group or DP group) based on the location of their neoplasms. Every subgroups will be divided into two parallel groups by the randomization of intervention plan(lap surgery or robotic surgery)
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| Laparoscopic pancreaticoduodenectomy |
| Procedure |
The Intervention of MIPD-LAP group |
|
| Robotic Distal Pancreatectomy | Procedure | The Intervention of MIDP-ROB group |
|
| Laparoscopic Distal Pancreatectomy | Procedure | The Intervention of MIDP-LAP group |
|
| up to 90 days |
| Grade B and C pancreatic fistula | The frequency of grade B or C pancreatic fistula | up to 90 days |
| QOL score | Quality of life after surgery, greater means higher life satisfaction | up to 90 days |
| Expense | The amount of treatment expense and certain procedure expense | during the treatment |
| 90-day death rate | The rate of death within 90 days after surgery | up to 90 days |
| The rate of spleen-preservation | For DP groups, the rate of spleen being preserved | up to 90 days |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |