Esophageal cancer Esophageal cancer, Esophagectomy, Collard, Anastomostic complication, Anastomostic leakage, Stenosis
Conditions
Interventions
During the remnant esophagus-gastric anastomosis, Tri-Staple 2.0 Reinforce Reload 45mm Purple with pre-attached absorbable suture reinforcement is used for the first stapling to perform a modified Col
D004938
Esophageal cancer, Esophagectomy, Collard, Anastomostic complication, Anastomostic leakage, Stenosis
Sponsors
Miyata Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 20 to 85 at the time of enrollment 2. Performance status (PS) is 0 or 1 according to ECOG criteria 3. Patients histologically diagnosed as either squamous cell carcinoma or adenocarcinoma by endoscopic biopsy of the primary esophageal tumor 4. cT1b-4b cases with preoperative diagnosis (regardless of presence or absence of lymph node metastasis/distant metastasis, preoperative treatment or content) (UICC-TNM8th) 5. Patients scheduled for radical subtotal esophagectomy + gastric tube reconstruction for histologically confirmed esophageal cancer (regardless of reconstruction route or stage 1/2 reconstruction) 6. Patients who plan to secure a residual esophagus of 5 cm or more and can reconstruct the residual esophagus-gastric anastomosis using the modified Collard method. 7. Cases with written consent from the patient
Exclusion criteria
Exclusion criteria: 1. Cases other than subtotal esophagectomy (lower esophagectomy, cervical esophagectomy, total pharyngolaryngoesophagectomy, etc.) 2. Patients planning reconstruction using a non-gastric tube 3. Cases with stricture in the cervical esophagus before surgery 4. Patients with a history of hypersensitivity to absorbable suture reinforcement material (polyglycolic acid) 5. Active multiple cancers (excluding multiple cancers that can be controlled by local treatment such as endoscopy or irradiation) 6. Cases deemed inappropriate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of anastomotic complications after surgery for esophageal cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence rate of anastomotic leakage, healing period after the onset of suture failure, postoperative hospital stay, the incidence rate of cervical surgical site infection (SSI), period to start of postoperative oral intake, postoperative hospital stay, anastomotic stenosis Onset rate, time of onset of anastomotic stenosis, the content of anastomotic stenosis treatment, recovery period of anastomotic stenosis, postoperative weight loss rate, postoperative body composition change, postoperative patient QOL evaluation | — |
Contacts
Public ContactTakahito Sugase
Osaka International Cancer Institute
Outcome results
None listed