Aprotinin; Human fibrinogen; Calcium chloride dihydrate; Human thrombin; Human coagulation factor XIII for Gastric cancer | Esophagojejunal anastomotic dehiscence

Inclusion criteria

• {"criterion_text":"- Patients of both sexes over 18 years of age.\n- Diagnosis of gastric cancer with AP of gastric adenocarcinoma and possibility of total gastrectomy with curative intent. Tumors with AP characteristics other than gastric adenocarcinoma are excluded (see ‘Exclusion Criteria’)\n- Patients undergoing surgery in trial participants hospital centers\n- understand and accept the trial procedures and sign an informed consent."}

Exclusion criteria

• {"criterion_text":"- Not meeting the inclusion criteria.\n- Intraoperative diagnosis (during surgery) of non-epithelial neoplasia,metastasis, patients with unresected tumor or undergoing palliative resections.\n- Use of other sealing or anastomosis reinforcing products other than the drug under study (TISSEEL Solutions for tissue adhesive)\n- Subjects who are intolerant or have experienced serious adverse events to products made from fibrin adhesive\n- Pregnant or lactating women\n- Subjects who are unable to understand the nature of the trial and the procedures they are required to follow.\n- Failure to sign the informed consent."}

Primary endpoints

• {"endpoint_text":"- Suture dehiscence diagnosed within the first seven days after surgery, using clinical and/or radiological parameters. Csendes classification","definition_or_measurement_approach":"Suture dehiscence diagnosed within the first seven days after surgery, using clinical and/or radiological parameters; classification by Csendes classification."}

Secondary endpoints

• {"endpoint_text":"- Type of anastomosis performed: manual, mechanical (circular or linear)","definition_or_measurement_approach":"Record type of anastomosis performed (manual, mechanical - circular or linear)."}
• {"endpoint_text":"- Amylases in drainage on days 1,3,5,7 postoperatively or until the drainage is removed.","definition_or_measurement_approach":"Measure amylase levels in drainage fluid on postoperative days 1, 3, 5 and 7 or until drain removal."}
• {"endpoint_text":"- Leukocytes, procalcitonin, C-reactive protein in blood on days 0,1,3,5,7 postoperatively.","definition_or_measurement_approach":"Measure blood leukocytes, procalcitonin and C-reactive protein on days 0, 1, 3, 5 and 7 postoperatively."}
• {"endpoint_text":"- Day of CT with oral contrast. CT findings according to Goense score","definition_or_measurement_approach":"CT with oral contrast performed on designated day; findings scored using Goense score."}
• {"endpoint_text":"- Postoperative complication and type (Clavien Dindo Classification)","definition_or_measurement_approach":"Record postoperative complications and grade them using Clavien-Dindo classification."}
• {"endpoint_text":"- Need for urgent surgical reintervention","definition_or_measurement_approach":"Record occurrence of urgent surgical reintervention."}
• {"endpoint_text":"- In-hospital and 90-day mortality","definition_or_measurement_approach":"Record mortality during hospital stay and at 90 days postoperatively."}
• {"endpoint_text":"- Date of hospital discharge","definition_or_measurement_approach":"Record date of hospital discharge."}
• {"endpoint_text":"- Readmissions at 30 and 90 days","definition_or_measurement_approach":"Record hospital readmissions occurring within 30 and 90 days postoperatively."}

Spain

Earliest CTIS Part Ii Submission Date

09-01-2025

Latest Decision Or Authorization Date

15-01-2025

Processing Time Days

6

Number Of Sites

13

Number Of Participants

240

Primary sponsor

Full Name

Hospital Germans Trias I Pujol

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"BAXTER, S.L.","duties_or_roles":"Marketing authorisation holder / product manufacturer (product: TISSEEL)","organisation_type":"Company"}