Oxygen saturation endoscopic imaging to assess bowel perfusion: a pilot study

JRCT ID: jRCTs032210075

Registered date:10/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Primary rectal cancer
• Date of first enrollment: 03/06/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): in surgery,1st postoperative day, 2nd postoperative day, 3rd postoperative day, 4th postoperative day, 5th post operative day, 6th postoperative day, 7th postoperative day and 28th postoperative day oxygen saturation Evaluation of intestinal blood flow using degree imaging

Outcome(s)

Primary Outcome

StO2 in the perfused area at the boundary betwee
n the perfused area and the ischemic area determi
ned by intraoperative blood flow evaluation by IC
G fluorescence

Secondary Outcome

Slope of StO2 curve at the boundary between perf
used area and ischemic area judged by intraopera
tive blood flow evaluation by ICG fluorescence
method
Distance between perfused area and ischemic are
a judged by intraoperative blood flow evaluation b
y OXEI and ICG fluorescence method
StO2 in intraoperative and postoperative evaluatio
n using OXEI
Hemoglobin index in intraoperative and postopera
tive evaluation using OXEI
Test equipment failure rate
Rate of adverse events of Grade 3 or higher and G
rade 4 or higher caused by test equipment
Incidence of suture failure

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Primary rectal cancer located within 12cm from the anal verge(with or without preoperativetreatment)
2)Histologically proven rectal adenocarcinoma orrectal neuroendocrine tumor
3)Planning elective surgery with excision and anastomosis
4)Age>=20
5)According to the clinical test results within 30 days before registration, the following organ functions are satisfied.
WBC>3,000mm^3
Hb>8.0g/dL
PLT>100,000mm^3
T-bil<2.0mg/dL
AST(GOT)<100U/L
ALT(GPT)<100U/L
Cr<1.5mg/dL
6)Performance Status ECOG:0 or 1
7)The consent in writing has obtained
*1 Regardless of open surgery/laparoscopic surgery
*2 Regardless of the reconstructive method
*3 Regardless of clinical stage
*4 Regardless of the degree of surgical cure
*5 With or without comorbidities
*6 Cases enrolled in other clinical trials are also acceptable

Exclude criteria

1) Emergency surgery is needed
2) Judged inappropriate for this trial

Related Information

• Primary Sponsor: Ito Masaaki
• Source(s) of Monetary Support: FUJIFILM Corporation