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Randomized comparison study(III phase)between manual inflation of the room air and Carbon dioxide(Co2) automatic inflation for the colon distension procedure during FDG-PET/C colonograph and CTA simultaneous examination as a preoperative colon cancer.

Randomized comparison study(III phase)between manual inflation of the room air and Carbon dioxide(Co2) automatic inflation for the colon distension procedure during FDG-PET/C colonograph and CTA simultaneous examination as a preoperative colon cancer. - Same as above.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009025
Enrollment
60
Registered
2012-10-03
Start date
2012-10-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer

Interventions

Manual air insufflation Automated carbon dioxide insufflation

Sponsors

Jinsenkai MI Clinic
Lead Sponsor
Osaka University gastroenterological surgery
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Palliative operation for Colon primary carcinoma 2.Diagnosed colon cancer histologically by endoscopic biopsy from the colon primary carcinoma lesion. 3.The tumor location comprehensively judged using endoscopic exam and preoperative imaging exam( abdomen, pelvis exam) are ceca, ascending colon, hepatic flexure, colon transversem, splenic fleure,colon descendens, colon signoideum, proctosigmoid, rectum. 4.Radically resectable under the laparoscopic colon resection. 5. Registration age is over 20y, less than 80y. 6.No anamnesis of intestine excision(including stomach, excluding appendectomy) 7.No anamnesis of chemotherapy a/o radiation therapy for treatment of malignancy like other cancer. 8. 0 or 1 of performance status(ECOG) 9. Functions other organotrophics. 10.Acquired Preoperative colon cancer multi-modal fusion exam consent. 11. Performed colon endoscopy exam at Osaka University Hospital just before the pre operative colon cancer multi-modal fusion exam. 12.Acquired patient consent to understand the purpose of this study and patient will to join this clinical study by having thoroughly explanation.

Exclusion criteria

Exclusion criteria: 1.Without satisfaction of selection std. 2.Active duplication cancer(synchronia duplication cancer as well as metachronous duplication cancer within 5 years of nondisease period. However, Carcinoma in situ healed by local therapy or lesion cancer in mucosa are not included in the active duplication cancer.) 3.Complicated insanity or mental disorder and judged the difficulty to join this study. 4.Non-controlable Diabates(HbA1c>=8.0%) 5.Need dialysis chronicity renal failure. 6.Continuous constitutional dose of steroid(via peroral or pervenous) or require state of immunosuppressant. 7.Severe heart disease case. 8.Having Pulmonary pneumatosis, fibrosis of lung 9.Continuous ingestion of analgetic including NSAIDs. 10.Complaining bellyache, distension just before the preoperative colon cancer multi-modal fusion exam. 11. In case of stomatosyte produced in Large intestine, small intestine. 12.Difficulity of walk by oneself. 13.In case of sever colon stenosis is informed before the colon cancer preoperative multi-modal fusion exam and study representative doctor or sub representative doctor judged no possibility of inflation to colon intestine. 14. eGFR calculated from Age, sexuality and serum creatine is less than 30 ml/min/1.73m2 15.In case of Iodo anaphyraxis. 16.Sever Anamnesis of thyroiditis 17. Anamnesis of iodo contrast media side effect. 18.Recognized intestine hemorrhage. 19.The others,In case of the doctor incharge judged inappropriate to join this study.

Design outcomes

Primary

MeasureTime frame
Colon CT imaging evaluation(intestine and lesion display ability) during preoperative colon cancer multi-mode fusion examination .

Secondary

MeasureTime frame
The degree of patient discomfort (pain, a sense of distension) Comparison of examination times Radiation dose to the examining staff measured during examination Estimated patient radiation dose

Countries

Japan

Contacts

Public ContactYasuo Iwamoto

Jinsenkai MI Clinic Research Secretariat

iwamoto@jinsen-pet.jp06-6840-0100.311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026