Colorectal CancerPELVINAVNCT03806244

Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer

A study testing Intraoperative acquisition (robotic c-Arm) of images in people with Colorectal Cancer, run by IHU Strasbourg at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To evaluate the feasibility and precision of stereotaxic navigation in laparoscopic surgery for colorectal cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
What is being tested?: Intraoperative acquisition (robotic c-Arm) of images
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteFrance
Study dates: 17 Jul 2019to 10 Oct 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is over 18 years old
Patient presents with cancer
Patient has no contraindication to anesthesia and surgical resection
Patient able to receive and understand information about the study and give written informed consent
Patient (s) affiliated to the national social security system.

Who cannot join

Patient operated on urgently.
Pregnant or lactating patient
Patient in an exclusion period (determined by previous or current study).
Patient under the protection of justice.
Patient under guardianship or curatorship.

Trial locations and contacts

1 site in 1 country.

France1 site

Service de Chirurgie Digestive et Endocrinienne, NHC
Strasbourg, 67 091

Other trials in France

About this study

Official title: Prospective Study of the Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer

To evaluate the feasibility and precision of stereotaxic navigation in laparoscopic surgery for colorectal cancer.

Read the detailed description

In minimally invasive surgery, the proper identification of the correct anatomical planes can be difficult due to a lack of tactile feedback and the inability to manually palpate the organ prior to resection. Although this can be minimized by careful preoperative planning, the information that can be obtained by images is also of limited utility. Conventional imaging, such as magnetic resonance imaging (MRI) and computed tomography (CT-scan), can provide a detailed view of 2D or 3D internal anatomical structures. However, during surgery, surgeons still have to use their subjective interpretation to translate this information into three-dimensional spatial relationships (ie the patient's actual volume). For this reason, in order to perform adequate resection and avoid injury, the surgeon must constantly infer what is the actual location of the anatomical structures and what is the position of the surgical instruments in relation thereto.
The proposed study aims to evaluate the feasibility of surgical navigation in patients with colorectal cancer (sigmoid rectum-right-left rectum) and measure its performance in the perspective of a more specific application to rectal cancer approached laparoscopically through the abdomen and / or the anus. The study is proposed to patients with cancer because the measurement of accuracy will be done on predefined anatomical points that will be detectable in the surgical field after oncologic dissection. Benign pathologies do not require this type of extensive dissection and the application of navigation would imply additional risks for patients.
Surgical navigation will be performed on the basis of preoperative images or intraoperative images.

Conditions: Colorectal Cancer
Being tested: Intraoperative acquisition (robotic c-Arm) of images
Keywords: stereotactic navigation, colorectal cancer, laparoscopy, transanal surgery
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intraoperative acquisition (robotic c-Arm) of imagesOther
Conventional laparoscopic colorectal oncologic resection is performed. During the procedure, the operator will identify previously defined anatomical landmarks, point them with an instrument tracked by the navigation system and the accuracy of the stereotactic navigation system will be calculated by comparing the "surgical" anatomical point and its correspondent on the images of the navigation platform.

Study groups in NCT03806244
Study group	Role	What they receive
PREOP	No intervention	Navigation without intraoperative acquisition of images: Use of conventional preoperative images (CT-MRI) to establish intraoperative navigation.
PEROP	Experimental	Navigation with intraoperative acquisition of images: Intraoperative acquisition (robotic c-Arm) of images to establish intraoperative navigation. Receives: Other: Intraoperative acquisition (robotic c-Arm) of images

What is being measured

The primary outcome is the main question the study is designed to answer.

Accuracy of Surgical stereotactic navigation defined as the distance, in millimetres, between the position of the surgical landmark and the position determined by the navigation system
Measurement of "accuracy" of surgical navigation defined as the distance measured between the position of "surgical" previously defined anatomical landmarks, pointed with a surgical instrument tracked by the navigation system, and corresponding location of the instrument in the navigation image. A distance equal to or less than 4 mm between the two locations will be considered as an optimum accuracy.
Measured: up to 7 days post procedure

Secondary outcomes (5)

Comparison, in millimeters, of the surgical navigation "accuracy" (as defined in the primary outcome) with or without intraoperative images acquisition
Usefulness of intraoperative images acquisition for the registration process of the navigation system by comparing accuracy of surgical navigation (in mm) with or without intraoperative images acquisition
Measured: up to 7 days post procedure
Difference, in millimetres, between the alignment of the geometric position of the markers in the image space and the actual physical space for stereotaxic navigation
Measurement of "registration error" during surgical navigation defined as the difference between the alignment of the geometric position of the markers in the image space and the actual physical space, with or without intraoperative images acquisition. An error of 2 mm during the recording process will be considered as the optimal parameter
Measured: up to 7 days post procedure
Measurement of the overall operating time (in minutes) with and without intraoperative images acquisition
Evaluation of the impact of the introduction of surgical navigation on the operating time. The measurement of the overall operating time (expressed in minutes), associated with surgical navigation
Measured: up to 30 days post procedure
Measurement of the level of radiation exposure to ionizing factors with and without intraoperative images acquisition
Evaluation of the impact of the introduction of surgical navigation on the exposure of the patient to ionizing radiation, measured with Dose Length Product (DLP) and expressed in mGy * cm
Measured: up to 30 days post procedure
Number of intra and/or postoperative complication
Evaluation of the impact of the introduction of surgical navigation on the incidence of intra- and / or postoperative complications associated with surgical navigation
Measured: up to 30 days post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 201910 Oct 2022

First posted16 Jan 2019
Study start17 Jul 2019
Primary completion10 Oct 2022
Study completion10 Oct 2022

Why it stopped: Departure of the two main investigators

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03806244
Sponsor's protocol ID: 18-002
Acronym: PELVINAV
Status last verified: Jan 2024
First submitted: 14 Jan 2019
Last updated: 8 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Marley AR, Nan H. Epidemiology of colorectal cancer. Int J Mol Epidemiol Genet. 2016 Sep 30;7(3):105-114. eCollection 2016.
PubMed 27766137
Arnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27.
PubMed 26818619
Biondi A, Vacante M, Ambrosino I, Cristaldi E, Pietrapertosa G, Basile F. Role of surgery for colorectal cancer in the elderly. World J Gastrointest Surg. 2016 Sep 27;8(9):606-613. doi: 10.4240/wjgs.v8.i9.606.
PubMed 27721923
Simmonds PC, Primrose JN, Colquitt JL, Garden OJ, Poston GJ, Rees M. Surgical resection of hepatic metastases from colorectal cancer: a systematic review of published studies. Br J Cancer. 2006 Apr 10;94(7):982-99. doi: 10.1038/sj.bjc.6603033.
PubMed 16538219
Rullier E, Sebag-Montefiore D. Sphincter saving is the primary objective for local treatment of cancer of the lower rectum. Lancet Oncol. 2006 Sep;7(9):775-7. doi: 10.1016/S1470-2045(06)70863-4. No abstract available.
PubMed 16945773
Orsini RG, Wiggers T, DeRuiter MC, Quirke P, Beets-Tan RG, van de Velde CJ, Rutten HJ. The modern anatomical surgical approach to localised rectal cancer. EJC Suppl. 2013 Sep;11(2):60-71. doi: 10.1016/j.ejcsup.2013.07.033. No abstract available.
PubMed 26217114
Abu Gazala M, Wexner SD. Re-appraisal and consideration of minimally invasive surgery in colorectal cancer. Gastroenterol Rep (Oxf). 2017 Feb;5(1):1-10. doi: 10.1093/gastro/gox001. Epub 2017 Feb 6.
PubMed 28567286
Bucholz RD. Introduction to Journal of Image Guided Surgery. J Image Guid Surg. 1995;1(1):1-3. doi: 10.1002/(SICI)1522-712X(1995)1:13.0.CO;2-E. No abstract available.
PubMed 9079420
Azagury DE, Dua MM, Barrese JC, Henderson JM, Buchs NC, Ris F, Cloyd JM, Martinie JB, Razzaque S, Nicolau S, Soler L, Marescaux J, Visser BC. Image-guided surgery. Curr Probl Surg. 2015 Dec;52(12):476-520. doi: 10.1067/j.cpsurg.2015.10.001. Epub 2015 Oct 22. No abstract available.
PubMed 26683419
Mezger U, Jendrewski C, Bartels M. Navigation in surgery. Langenbecks Arch Surg. 2013 Apr;398(4):501-14. doi: 10.1007/s00423-013-1059-4. Epub 2013 Feb 22.
PubMed 23430289
Pruliere-Escabasse V, Coste A. Image-guided sinus surgery. Eur Ann Otorhinolaryngol Head Neck Dis. 2010 Mar;127(1):33-9. doi: 10.1016/j.anorl.2010.02.009. Epub 2010 Mar 24.
PubMed 20822755
Risholm P, Golby AJ, Wells W 3rd. Multimodal image registration for preoperative planning and image-guided neurosurgical procedures. Neurosurg Clin N Am. 2011 Apr;22(2):197-206, viii. doi: 10.1016/j.nec.2010.12.001.
PubMed 21435571
Fitzpatrick JM. The role of registration in accurate surgical guidance. Proc Inst Mech Eng H. 2010;224(5):607-22. doi: 10.1243/09544119JEIM589.
PubMed 20718266
Wittmann W, Wenger T, Zaminer B, Lueth TC. Automatic correction of registration errors in surgical navigation systems. IEEE Trans Biomed Eng. 2011 Oct;58(10):2922-30. doi: 10.1109/TBME.2011.2163156. Epub 2011 Jul 29.
PubMed 21803677
Gundle KR, White JK, Conrad EU, Ching RP. Accuracy and Precision of a Surgical Navigation System: Effect of Camera and Patient Tracker Position and Number of Active Markers. Open Orthop J. 2017 May 31;11:493-501. doi: 10.2174/1874325001711010493. eCollection 2017.
PubMed 28694888

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Study of the Feasibility of Stereotactic Navigation in Laparoscopic Surgery for Colorectal Cancer
ClinicalTrials.gov ID: NCT03806244
Acronym / sponsor ID: PELVINAV / 18-002
Conditions: Colorectal Cancer
Keywords: stereotactic navigation, colorectal cancer, laparoscopy, transanal surgery
Study type: Interventional
Recruitment status: TerminatedReason stopped: Departure of the two main investigators
Enrolment: 12 participants (actual)
Lead sponsor: IHU StrasbourgUniversity, hospital or other
Study start: 17 Jul 2019 (actual)
Primary completion: 10 Oct 2022 (actual)
Study completion: 10 Oct 2022 (actual)
First posted: 16 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the feasibility and precision of stereotaxic navigation in laparoscopic surgery for colorectal cancer.

Detailed description

In minimally invasive surgery, the proper identification of the correct anatomical planes can be difficult due to a lack of tactile feedback and the inability to manually palpate the organ prior to resection. Although this can be minimized by careful preoperative planning, the information that can be obtained by images is also of limited utility. Conventional imaging, such as magnetic resonance imaging (MRI) and computed tomography (CT-scan), can provide a detailed view of 2D or 3D internal anatomical structures. However, during surgery, surgeons still have to use their subjective interpretation to translate this information into three-dimensional spatial relationships (ie the patient's actual volume). For this reason, in order to perform adequate resection and avoid injury, the surgeon must constantly infer what is the actual location of the anatomical structures and what is the position of the surgical instruments in relation thereto.
The proposed study aims to evaluate the feasibility of surgical navigation in patients with colorectal cancer (sigmoid rectum-right-left rectum) and measure its performance in the perspective of a more specific application to rectal cancer approached laparoscopically through the abdomen and / or the anus. The study is proposed to patients with cancer because the measurement of accuracy will be done on predefined anatomical points that will be detectable in the surgical field after oncologic dissection. Benign pathologies do not require this type of extensive dissection and the application of navigation would imply additional risks for patients.
Surgical navigation will be performed on the basis of preoperative images or intraoperative images.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PREOP	No intervention	–Navigation without intraoperative acquisition of images: Use of conventional preoperative images (CT-MRI) to establish intraoperative navigation.
PEROP	Experimental	Other: Intraoperative acquisition (robotic c-Arm) of imagesNavigation with intraoperative acquisition of images: Intraoperative acquisition (robotic c-Arm) of images to establish intraoperative navigation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patient is over 18 years old
Patient presents with cancer
Patient has no contraindication to anesthesia and surgical resection
Patient able to receive and understand information about the study and give written informed consent
Patient (s) affiliated to the national social security system.

Key exclusion criteria (5 listed)

Patient operated on urgently.
Pregnant or lactating patient
Patient in an exclusion period (determined by previous or current study).
Patient under the protection of justice.
Patient under guardianship or curatorship.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intraoperative acquisition (robotic c-Arm) of imagesConventional laparoscopic colorectal oncologic resection is performed. During the procedure, the operator will identify previously defined anatomical landmarks, point them with an instrument tracked by the navigation system and the accuracy of the stereotactic navigation system will be calculated by comparing the "surgical" anatomical point and its correspondent on the images of the navigation platform.	Other	PEROP

Primary outcome

Accuracy of Surgical stereotactic navigation defined as the distance, in millimetres, between the position of the surgical landmark and the position determined by the navigation system
Time frame: up to 7 days post procedure
Measurement of "accuracy" of surgical navigation defined as the distance measured between the position of "surgical" previously defined anatomical landmarks, pointed with a surgical instrument tracked by the navigation system, and corresponding location of the instrument in the navigation image. A distance equal to or less than 4 mm between the two locations will be considered as an optimum accuracy.

5 secondary outcomes

Comparison, in millimeters, of the surgical navigation "accuracy" (as defined in the primary outcome) with or without intraoperative images acquisition
Time frame: up to 7 days post procedure
Difference, in millimetres, between the alignment of the geometric position of the markers in the image space and the actual physical space for stereotaxic navigation
Time frame: up to 7 days post procedure
Measurement of the overall operating time (in minutes) with and without intraoperative images acquisition
Time frame: up to 30 days post procedure
Measurement of the level of radiation exposure to ionizing factors with and without intraoperative images acquisition
Time frame: up to 30 days post procedure
Number of intra and/or postoperative complication
Time frame: up to 30 days post procedure

Results and safety

The study was stopped early (reason given: Departure of the two main investigators). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
Background: PubMed 27766137Marley AR, Nan H. Epidemiology of colorectal cancer. Int J Mol Epidemiol Genet. 2016 Sep 30;7(3):105-114. eCollection 2016.
Background: PubMed 26818619Arnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27.
Background: PubMed 27721923Biondi A, Vacante M, Ambrosino I, Cristaldi E, Pietrapertosa G, Basile F. Role of surgery for colorectal cancer in the elderly. World J Gastrointest Surg. 2016 Sep 27;8(9):606-613. doi: 10.4240/wjgs.v8.i9.606.
Background: PubMed 16538219Simmonds PC, Primrose JN, Colquitt JL, Garden OJ, Poston GJ, Rees M. Surgical resection of hepatic metastases from colorectal cancer: a systematic review of published studies. Br J Cancer. 2006 Apr 10;94(7):982-99. doi: 10.1038/sj.bjc.6603033.
Background: PubMed 16945773Rullier E, Sebag-Montefiore D. Sphincter saving is the primary objective for local treatment of cancer of the lower rectum. Lancet Oncol. 2006 Sep;7(9):775-7. doi: 10.1016/S1470-2045(06)70863-4. No abstract available.
Background: PubMed 26217114Orsini RG, Wiggers T, DeRuiter MC, Quirke P, Beets-Tan RG, van de Velde CJ, Rutten HJ. The modern anatomical surgical approach to localised rectal cancer. EJC Suppl. 2013 Sep;11(2):60-71. doi: 10.1016/j.ejcsup.2013.07.033. No abstract available.
Background: PubMed 28567286Abu Gazala M, Wexner SD. Re-appraisal and consideration of minimally invasive surgery in colorectal cancer. Gastroenterol Rep (Oxf). 2017 Feb;5(1):1-10. doi: 10.1093/gastro/gox001. Epub 2017 Feb 6.
Background: PubMed 9079420Bucholz RD. Introduction to Journal of Image Guided Surgery. J Image Guid Surg. 1995;1(1):1-3. doi: 10.1002/(SICI)1522-712X(1995)1:13.0.CO;2-E. No abstract available.
Background: PubMed 26683419Azagury DE, Dua MM, Barrese JC, Henderson JM, Buchs NC, Ris F, Cloyd JM, Martinie JB, Razzaque S, Nicolau S, Soler L, Marescaux J, Visser BC. Image-guided surgery. Curr Probl Surg. 2015 Dec;52(12):476-520. doi: 10.1067/j.cpsurg.2015.10.001. Epub 2015 Oct 22. No abstract available.
Background: PubMed 23430289Mezger U, Jendrewski C, Bartels M. Navigation in surgery. Langenbecks Arch Surg. 2013 Apr;398(4):501-14. doi: 10.1007/s00423-013-1059-4. Epub 2013 Feb 22.
Background: PubMed 20822755Pruliere-Escabasse V, Coste A. Image-guided sinus surgery. Eur Ann Otorhinolaryngol Head Neck Dis. 2010 Mar;127(1):33-9. doi: 10.1016/j.anorl.2010.02.009. Epub 2010 Mar 24.
Background: PubMed 21435571Risholm P, Golby AJ, Wells W 3rd. Multimodal image registration for preoperative planning and image-guided neurosurgical procedures. Neurosurg Clin N Am. 2011 Apr;22(2):197-206, viii. doi: 10.1016/j.nec.2010.12.001.
Image-guided navigation surgery for pelvic malignancies using electromagnetic tracking - Proceedings of the SPIELink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Didier Mutter, MD, PhD principal investigator

Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intraoperative acquisition (robotic c-Arm) of images in people with Colorectal Cancer, run by IHU Strasbourg at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Departure of the two main investigators). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of Surgical stereotactic navigation defined as the distance, in millimetres, between the position of the surgical landmark and the position determined by the navigation system (time frame: up to 7 days post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03806244, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.