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Minimally invasive pancreaticoduodenectomy remains one of the most challenging abdominal procedures. Safety and feasibility remain controversial when comparing minimally-invasive with open pancreaticoduodenectomy, especially for malignant tumors.The aim of this study was to compare minimally invasive and open pancreatoduodenectomy for short-term outcomes and long-term follow-up in a randomized trial.
This study is to compare the efficiency and safety between minimally invasive (including laparoscopic and robotic) and open pancreaticoduodenectomy for pancreatic cancer. We design a prospective randomized study. Patients with malignant pancreatic tumor who underwent pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible patients are randomly allocated to minimally-invasive or open group before the operation day. The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate as well as disease free survival and overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally-invasive Pancreaticoduodenectomy | Experimental | MIPD |
|
| Open Pancreaticoduodenectomy | Placebo Comparator | OPD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally-invasive pancreaticoduodenectomy | Procedure | Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall complications | The proportion of all complications after operation accounted for the total number of patients | Up to postoperative 30 days |
| Pancreatic fistula | The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course. | Up to postoperative 30 days |
| Intra-abdominal bleeding | The International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration. | Up to postoperative 30 days |
| Intra-abdominal infection | Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test. | Up to postoperative 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay (day) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | Up to postoperative 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | The period between the beginning of treatment and the observation of disease progression or the occurrence of death for any reason. | Up to postoperative 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Menghua Dai, MD | Contact | +861069152600 | DaiMH@pumch.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 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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| Open pancreaticoduodenectomy | Other | Open pancreaticoduodenectomy for resection of pancreatic tumor |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |