Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis

Sigmoid Diverticulosis Clinical Trial

— PERFECT  

Official title:

Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626091
• Other study ID #: 15-005
• Status: Completed
• Phase: N/A
• Start date: September 14, 2016
• Est. completion date: September 14, 2018

Study information

• Verified date: February 2021
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the ability of a ICG-fluorescence guidance complemented with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to validate the accuracy of this technique with metabolic intestinal cells changes.

Description:

Accurate intraoperative evaluation of peri-anastomotic gastrointestinal tract perfusion is essential to reduce the risk of anastomotic complications such as leakage or strictures. Anastomotic leakage is the most dreadful complication of colorectal resections.

Intestinal microcirculation and viability is usually estimated from the color of the serosal surface, presence of peristalsis, pulsation and bleeding from the marginal arteries. This is subjective and based on the experience of the surgeon.

Fluorescence videography integrates a near-infrared endoscope able to detect the signal emitted by a fluorescent dye, Indocyanine Green (ICG), which is administered by intravenous injection. Fluorescence intensity is proportional to the amount of fluorescent dye diffused in the tissue and it consequently is a surrogate marker of tissue perfusion.

The hypothesis is that ICG-fluorescence guidance coupled with enhanced reality would allow a precise and rapid localization of the future anastomotic site in terms of optimal perfusion in laparoscopic colorectal resections.

In patients undergoing elective left-sided colonic resection by laparoscopic approach, resection site and anastomosis perfusion will be evaluated by :

• the visual appreciation of the surgeon

• the fluorescence-based enhanced reality, after injection of ICG and digital process.

A series of peri-operative samplings will also be carried out. In any case, the resection will be performed according to the surgeon's appreciation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 14, 2018
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient, male or female, from 18 years old

• Patient with sigmoid diverticulosis or diverticulitis

• Patient with colon malignancy

• Patient with rectum malignancy

• Patient with no contraindication to anesthesia and to colonic resection surgery

• Patient able to understand the study and to provide informed consent

• Patient affiliated to the French social security system

Exclusion Criteria:

• Patient undergoing emergency surgery

• Patient undergoing abdomino-perineal resection

• Patient undergoing colonic resection without anastomosis (Hartmann's colostomy)

• Patient with proven or unclear allergic reactions

• Pregnancy or breast-feeding

• Patient in exclusion period (determined by a previous study or in progress)

• Patient in custody

• Patient under guardianship

Related Conditions & MeSH terms

• Colorectal Malignancy
• Diverticulitis
• Diverticulum
• Sigmoid Diverticulitis
• Sigmoid Diverticulosis

Intervention

Procedure:
• Left-sided colonic resection
During interventions, anastomosis perfusion will be estimated (outcomes: visual appreciation of the surgeon, ICG fluorescence-based enhanced reality and series of peri-operative samplings) in order to validate the accuracy of ICG fluorescence-based enhanced reality technique. In any case, the resection will be performed according to the surgeon's appreciation.

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (5)

Boni L, David G, Mangano A, Dionigi G, Rausei S, Spampatti S, Cassinotti E, Fingerhut A. Clinical applications of indocyanine green (ICG) enhanced fluorescence in laparoscopic surgery. Surg Endosc. 2015 Jul;29(7):2046-55. doi: 10.1007/s00464-014-3895-x. Epub 2014 Oct 11. — View Citation

Diana M, Agnus V, Halvax P, Liu YY, Dallemagne B, Schlagowski AI, Geny B, Diemunsch P, Lindner V, Marescaux J. Intraoperative fluorescence-based enhanced reality laparoscopic real-time imaging to assess bowel perfusion at the anastomotic site in an experimental model. Br J Surg. 2015 Jan;102(2):e169-76. doi: 10.1002/bjs.9725. — View Citation

Diana M, Dallemagne B, Chung H, Nagao Y, Halvax P, Agnus V, Soler L, Lindner V, Demartines N, Diemunsch P, Geny B, Swanström L, Marescaux J. Probe-based confocal laser endomicroscopy and fluorescence-based enhanced reality for real-time assessment of intestinal microcirculation in a porcine model of sigmoid ischemia. Surg Endosc. 2014 Nov;28(11):3224-33. doi: 10.1007/s00464-014-3595-6. Epub 2014 Jun 17. — View Citation

Diana M, Halvax P, Dallemagne B, Nagao Y, Diemunsch P, Charles AL, Agnus V, Soler L, Demartines N, Lindner V, Geny B, Marescaux J. Real-time navigation by fluorescence-based enhanced reality for precise estimation of future anastomotic site in digestive surgery. Surg Endosc. 2014 Nov;28(11):3108-18. doi: 10.1007/s00464-014-3592-9. Epub 2014 Jun 10. — View Citation

Diana M, Noll E, Diemunsch P, Dallemagne B, Benahmed MA, Agnus V, Soler L, Barry B, Namer IJ, Demartines N, Charles AL, Geny B, Marescaux J. Enhanced-reality video fluorescence: a real-time assessment of intestinal viability. Ann Surg. 2014 Apr;259(4):700-7. doi: 10.1097/SLA.0b013e31828d4ab3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the perfusion evaluated by the ICG fluorescence-based enhanced reality and the metabolic state of the intestine	The perfusion evaluated by the ICG fluorescence-based enhanced reality, obtained by the digital process of the fluorescence dynamic signal, will be correlated to the metabolic state of the intestine, assessed by the measure of biological markers on several points of the intestine.	During surgery
Secondary	Correlation between the intraoperative intestinal perfusion and the rate of anastomosis leakage	The intraoperative intestinal perfusion on the anastomosis site, measured by fluorescence videography, will be correlated to the rate of anastomosis leakage.	During surgery
Secondary	Distance between the resection site based on the surgeon's appreciation and the resection site based on the digital analysis and the peri-operative samplings	The distance between the resection site based on the surgeon's clinic appreciation and the resection site based on the digital analysis and the level of capillary lactates and mitochondria respiratory rate on different sites will be measured.	During surgery