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

Not Applicable

• Conditions: Primary rectal cancer

• Registration Number: JPRN-jRCTs032210075
• Lead Sponsor: Ito Masaaki

Brief Summary

The mean(SD) deviation of the distance between the boundary between the perfusion area and the ischemic area in the reconstructed intestinal tract (oral) judged by intraoperative blood flow evaluation by OXEI and ICG fluorescence before anastomosis was 3.5(7.9)mm, suggesting that OXEI may be able to evaluate blood flow in the same way as ICG fluorescence.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-10
• Study Completion: 2022-04-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion 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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
StO2 in the perfused area at the boundary betwee<br>n the perfused area and the ischemic area determi<br>ned by intraoperative blood flow evaluation by IC<br>G fluorescence

Secondary Outcome Measures

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