Cervical drainage tube trial

JRCT ID: jRCT1052180016

Registered date:27/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 26/07/2018
• Target sample size: 110
• Study type: Interventional
• Intervention(s): Detention of the 15Fr blake silicon drain around the cervical anastomosis in thoracic esophagectomy

Outcome(s)

• Primary Outcome: Anastomotic leakage rate
• Secondary Outcome: Dose of used analgesics during the hospital admission period

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1)Histologically proven squamous cell carcinoma, adenosquamous cell carcinoma or basaloid squamous cell carcinoma of the intrathoracic esophagus.
2) Cancer is located in thoracic esoophagus.
3) Single or multi lesions are both included. Cervical esophageal lesion that will be treatedd by EMR/ESD can be included.
4) Clinical stageI, II, III (not included cT4) is suitable. In NAC cases, 1;clinical stageIB,II,III (not included cT4) tumors before NAC, 2;not cT4 or distant metastases after NAC, are necessary.
5)Age more than 20 and less than 85 years.
6)Performance status 0,1.
7) No history of esophagecl cancer treatment without 1;pT1a leasion treated by EMR/ESD, 2;cStageIB,II,III (not included cT4) treated by NAC,3;metachronous double cancer treated by EMR/ESD
8) Written informed consent.

Exclude criteria

1)Existence of systematic severe infection.
2)During the period of pregnancy (woman).
3)Existence of mental disease.
4)Whole body administration of steroid or immunosuppressive agent.
5)Existence of severe DM despite the fact that administration of continuous insulin.

Related Information

• Primary Sponsor: Oshikiri Taro
• Secondary ID(s): UMIN000031244