Clinical trial NCT02626091: Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis
Official title: Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sigmoid Diverticulosis
Sigmoid Diverticulitis
Colorectal Malignancy
Keywords: Anastomotic perfusion
ICG Fluorescence
Enhanced reality
Left-sided colonic resection
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between the perfusion evaluated by the ICG fluorescence-based enhanced reality and the metabolic state of the intestine
timeFrame: During surgery
Secondary outcomes:
measure: Correlation between the intraoperative intestinal perfusion and the rate of anastomosis leakage
timeFrame: During surgery
measure: 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
timeFrame: During surgery
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Study officials:
affiliation: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg
name: Didier Mutter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IHU Strasbourg
name: Michele Diana, MD
role: STUDY_DIRECTOR
References:
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.
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.
citation: Diana M, Dallemagne B, Chung H, Nagao Y, Halvax P, Agnus V, Soler L, Lindner V, Demartines N, Diemunsch P, Geny B, Swanstrom 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.
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.
citation: 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.
citation: D'Urso A, Agnus V, Barberio M, Seeliger B, Marchegiani F, Charles AL, Geny B, Marescaux J, Mutter D, Diana M. Computer-assisted quantification and visualization of bowel perfusion using fluorescence-based enhanced reality in left-sided colonic resections. Surg Endosc. 2021 Aug;35(8):4321-4331. doi: 10.1007/s00464-020-07922-9. Epub 2020 Aug 27.