Benign or low-grade malignant tumors in the body and tail of the pancreas
Conditions
Interventions
Standard treatment group (group A): Laparoscopic approach In the laparoscopic approach group, spleen-preserving distal pancreatectomy is performed laparoscopically, preserving the splenic artery and
Sponsors
Tokai University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Spleen-preserving distal pancreatectomy is planned for pancreatic tumors (however, preoperative biopsy is not required and clinical diagnosis is acceptable). Pancreatic metastasis from renal cancer without preoperative treatment is acceptable. 2) ASA-PS (American Society of Anesthesiology, General condition classification) is Class 1-3. 3) Age is over 18 years old. 4) He/she has sufficient judgment to understand the content of the research and has obtained written consent from the person himself/herself.
Exclusion criteria
Exclusion criteria: 1) Patients diagnosed with pancreatic adenocarcinoma or invasive intraductal papillary mucinous carcinoma (IPMC) by imaging diagnosis 2) Patients with severe ischemic heart disease 3) Patients with cirrhosis or active hepatitis requiring treatment 4) Patients with dyspnea requiring oxygen administration 5) Patients undergoing dialysis due to chronic renal failure 6) Long-term oral steroids that may affect adverse events 7) Patients who are considered to have difficulty participating in the study due to psychosis or psychiatric symptoms. 8) Patients who cannot use both iodine drugs and gadnium drugs due to severe drug allergy 9) Cases where the prescribed procedure is difficult due to history of upper abdominal surgery such as stomach, spleen, kidney, liver, transverse colon, retroperitoneum including pancreas and pancreatitis 10) Cases where combined resection of organs other than the gallbladder, bladder, and uterine appendages is suspected to be necessary 11) Other subjects deemed inappropriate by the principal investigator or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spleen preservation rate by preserving the splenic artery and vein | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical data: surgery time, laparotomy conversion rate, blood loss, blood transfusion, spleen preservation rate in the resected pancreatic parenchymal length >5cm and <5cm groups, number of sutures for hemostasis in the splenic artery and vein Postoperative complications: splenic artery and vein patency rate 3 months after surgery, incidence rate of partial splenic infarction of 50% or more, incidence of each Grade of pancreatic fistula, incidence of delayed gastric excretion (DGE) Grade B/C, incidence of intraperitoneal hemorrhage (PPH) Grade B/C, incidence of all postoperative complications, surgical death proportion Pathological diagnosis: histopathological diagnosis, tumor size | — |
Countries
Japan
Contacts
Public ContactShigenori Ei
Tokai University Department of Gastrointestinal Surgery
Outcome results
None listed