reinforcement trial

Phase 3

Recruiting

• Conditions: Esophageal cancer; Esophageal cancer, Esophagectomy, Collard, Anastomostic complication, Anastomostic leakage, Stenosis; D004938

• Registration Number: JPRN-jRCT1052230010
• Lead Sponsor: Miyata Hiroshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified