Disorder of Upper Gastrointestinal TractNCT01360411
Tissue Characterisation by Endoscopic GI-elastography
An observational study of Disorder of Upper Gastrointestinal Tract and Pancreatic Nodule, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
In this single centre study we study the use of endoscopic ultrasonography (EUS) combined with elastography in order to separate malignant tissue from benign tissue in and adjacent to the upper gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Disorder of Upper Gastrointestinal Tract, Pancreatic Nodule, Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph Nodes
- How many people
- 137 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2007to Jul 2012
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients referred to EUS examination or relevant surgery at Haukeland University Hospital, bergen, Norway within the inclusion period (2007- January 2011).
Who may be able to join
- Solid focal lesions in pancreas or pancreatitis
- Intramural lesions in esophagus, ventricle or duodenum
- Lymph nodes or tumour > 1 cm in mediastinum or retroperitoneum accessible by EUS
Who cannot join
- Cystic pancreatic lesions
- Patients where the histology or cytology of the lesion in question is known at the time of examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tissue Characterisation Using Ultrasound Based Strain Imaging(Elastography)Examining Lesions in the Gastrointestinal Wall, Adjacent Lymph Nodes and Pancreatic Lesions
In this single centre study we study the use of endoscopic ultrasonography (EUS) combined with elastography in order to separate malignant tissue from benign tissue in and adjacent to the upper gastrointestinal tract.
Read the detailed description
The purpose of this study is to use endoscopic ultrasonography (EUS) with strain based elastography to identify strain traits separating malignant from benign lesions. We are registering feasibility of endoscopic strain imaging and compare diagnostic accuracy of EUS + elastography with previous data on EUS alone.
Inclusion criteria:
- Group 1: Focal subepithelial lesions in esophageal, ventricular or duodenal wall discovered by endoscopy or other imaging modality.
- Group 2: Pancreatic lesion discovered by other imaging modality.
- Group 3: Mediastinal or retroperitoneal lymph node or tumor discovered by other imaging modality.
Histology of lesions should not be known at the time of examination. EUS elastography findings are evaluated shortly after the examination and categorised by different methods; categorical score, VAS, Strain Ratio. The result is then compared to histology or cytology results. Patients who do not undergo tissue sampling are followed up to discover disease progress.
- Conditions
- Disorder of Upper Gastrointestinal Tract, Pancreatic Nodule, Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph Nodes, Secondary Malignant Neoplasm of Lymph Node
- Keywords
- elastography, strain ratio, pancreas, GI wall lesions, lymph nodes
- Medical subject headings
- Neoplasm Metastasis, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic lesions | Any patient with a solid pancreatic lesion of unknown histology may be recruited. Cystic lesions are not included. Elastography findings are classified and compared to cytology or histology if the standard procedures or treatment provide this. In other cases the patients are being followed up conservatively. | |
| Intramural upper GI-lesions | Patients with intramural lesions discovered by endoscopy or other imaging modalities are recruited. Elastography findings are classified and compared to cytology or histology if the standard procedures or treatment provide this. In other cases the patients are being followed up conservatively. | |
| Lymph nodes | Patients with visible mediastinal lymph nodes or retroperitoneal lymph nodes in patients with inflammatory or malignant diseases are recruited. Elastography findings are classified and compared to cytology or histology if the standard procedures or treatment provide this. In other cases the patients are being followed up conservatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignant or benign lesion
Imaged lesions are sampled, surgically removed or followed up > 6 months to conclude on their nature. Images are evaluated, measured and categorised shortly after examination and compared to histological, cytological or follow up result. Elastography results do not interfere with surgical or oncological treatment planning in this study.
Measured: Jan 2007 - September 2011 + 6 months( if no tissue sample)(4 years)
Secondary outcomes (4)
Description of lesion elasticity
To identify softer and harder areas within and adjacent to focal lesions which could identify smooth surface, necrotic centre, regional fibrosis or regional cacncer.
Measured: 2007- September 2011 (4 years)
Value of Strain Ratio measurements
Strain ratio provides opportunity to compare strain in user selected areas of the elastogram. This is a semi-quantification of strain differences and may be useful for a better distinction between malignant ond non-malignant lesions.
Measured: 2007 - September 2011 (4 years)
Value of colour and pattern category
Categorisation of images of lesions using a published categorising scheme and comparision to cytology, histology or follow up.
Measured: 2007 - September 2011 (4 years)
Value of a Visual Analog Scale for strain image categorisation
Evaluation of the use of a simple 100 mm Visual analog scale to classify if lesion appears softer, equal to or harder than the surrounding tissue is useful for creating semiquantitative cut-off levels between malignant and benign lesions.
Measured: 2007 - September 2011 (4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startJan 2007
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Disorder of Upper Gastrointestinal TractStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Principal investigator, Roald Flesland Havre, Haukeland University Hospital
- Investigators
- Lars Birger Nesje, MD, PhD, Study director, University of BergenRoald F. Havre, MD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360411
- Sponsor's protocol ID
- 17765
- Status last verified
- Sep 2012
- First submitted
- 26 Apr 2010
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Waage JE, Havre RF, Odegaard S, Leh S, Eide GE, Baatrup G. Endorectal elastography in the evaluation of rectal tumours. Colorectal Dis. 2011 Oct;13(10):1130-7. doi: 10.1111/j.1463-1318.2010.02440.x.
PubMed 21040360Havre RF, Elde E, Gilja OH, Odegaard S, Eide GE, Matre K, Nesje LB. Freehand real-time elastography: impact of scanning parameters on image quality and in vitro intra- and interobserver validations. Ultrasound Med Biol. 2008 Oct;34(10):1638-50. doi: 10.1016/j.ultrasmedbio.2008.03.009. Epub 2008 Jun 4.
PubMed 18524458Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J, Arcidiacono P, Will U, Giovannini M, Dietrich C, Havre R, Gheorghe C, McKay C, Gheonea DI, Ciurea T; European EUS Elastography Multicentric Study Group. Accuracy of endoscopic ultrasound elastography used for differential diagnosis of focal pancreatic masses: a multicenter study. Endoscopy. 2011 Jul;43(7):596-603. doi: 10.1055/s-0030-1256314. Epub 2011 Mar 24.
PubMed 21437851Havre RF, Waage JR, Gilja OH, Odegaard S, Nesje LB. Real-Time Elastography: Strain Ratio Measurements Are Influenced by the Position of the Reference Area. Ultraschall Med. 2012 Dec;33(6):559-568. doi: 10.1055/s-0031-1273247. Epub 2011 Jun 10.
PubMed 21667433Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J, Arcidiacono P, Will U, Giovannini M, Dietrich CF, Havre R, Gheorghe C, McKay C, Gheonea DI, Ciurea T; European EUS Elastography Multicentric Study Group. Efficacy of an artificial neural network-based approach to endoscopic ultrasound elastography in diagnosis of focal pancreatic masses. Clin Gastroenterol Hepatol. 2012 Jan;10(1):84-90.e1. doi: 10.1016/j.cgh.2011.09.014. Epub 2011 Oct 1.
PubMed 21963957
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Characterisation Using Ultrasound Based Strain Imaging(Elastography)Examining Lesions in the Gastrointestinal Wall, Adjacent Lymph Nodes and Pancreatic Lesions
- ClinicalTrials.gov ID
- NCT01360411
- Acronym / sponsor ID
- 17765
- Conditions
- Disorder of Upper Gastrointestinal Tract, Pancreatic Nodule, Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph Nodes, Secondary Malignant Neoplasm of Lymph Node
- Keywords
- elastography, strain ratio, pancreas, GI wall lesions, lymph nodes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- Jan 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 May 2011 (estimated)
- 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.
In this single centre study we study the use of endoscopic ultrasonography (EUS) combined with elastography in order to separate malignant tissue from benign tissue in and adjacent to the upper gastrointestinal tract.
Detailed description
The purpose of this study is to use endoscopic ultrasonography (EUS) with strain based elastography to identify strain traits separating malignant from benign lesions. We are registering feasibility of endoscopic strain imaging and compare diagnostic accuracy of EUS + elastography with previous data on EUS alone.
Inclusion criteria:
- Group 1: Focal subepithelial lesions in esophageal, ventricular or duodenal wall discovered by endoscopy or other imaging modality.
- Group 2: Pancreatic lesion discovered by other imaging modality.
- Group 3: Mediastinal or retroperitoneal lymph node or tumor discovered by other imaging modality.
Histology of lesions should not be known at the time of examination. EUS elastography findings are evaluated shortly after the examination and categorised by different methods; categorical score, VAS, Strain Ratio. The result is then compared to histology or cytology results. Patients who do not undergo tissue sampling are followed up to discover disease progress.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pancreatic lesions | – | –Any patient with a solid pancreatic lesion of unknown histology may be recruited. Cystic lesions are not included. Elastography findings are classified and compared to cytology or histology if the standard procedures or treatment provide this. In other cases the patients are being followed up conservatively. |
| Intramural upper GI-lesions | – | –Patients with intramural lesions discovered by endoscopy or other imaging modalities are recruited. Elastography findings are classified and compared to cytology or histology if the standard procedures or treatment provide this. In other cases the patients are being followed up conservatively. |
| Lymph nodes | – | –Patients with visible mediastinal lymph nodes or retroperitoneal lymph nodes in patients with inflammatory or malignant diseases are recruited. Elastography findings are classified and compared to cytology or histology if the standard procedures or treatment provide this. In other cases the patients are being followed up conservatively. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients referred to EUS examination or relevant surgery at Haukeland University Hospital, bergen, Norway within the inclusion period (2007- January 2011).
Key inclusion criteria (3 listed)
- Solid focal lesions in pancreas or pancreatitis
- Intramural lesions in esophagus, ventricle or duodenum
- Lymph nodes or tumour > 1 cm in mediastinum or retroperitoneum accessible by EUS
Key exclusion criteria (2 listed)
- Cystic pancreatic lesions
- Patients where the histology or cytology of the lesion in question is known at the time of examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Malignant or benign lesion
Time frame: Jan 2007 - September 2011 + 6 months( if no tissue sample)(4 years)
Imaged lesions are sampled, surgically removed or followed up > 6 months to conclude on their nature. Images are evaluated, measured and categorised shortly after examination and compared to histological, cytological or follow up result. Elastography results do not interfere with surgical or oncological treatment planning in this study.
4 secondary outcomes
Description of lesion elasticity
Time frame: 2007- September 2011 (4 years)
Value of Strain Ratio measurements
Time frame: 2007 - September 2011 (4 years)
Value of colour and pattern category
Time frame: 2007 - September 2011 (4 years)
Value of a Visual Analog Scale for strain image categorisation
Time frame: 2007 - September 2011 (4 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
- Background: PubMed 21040360Waage JE, Havre RF, Odegaard S, Leh S, Eide GE, Baatrup G. Endorectal elastography in the evaluation of rectal tumours. Colorectal Dis. 2011 Oct;13(10):1130-7. doi: 10.1111/j.1463-1318.2010.02440.x.
- Background: PubMed 18524458Havre RF, Elde E, Gilja OH, Odegaard S, Eide GE, Matre K, Nesje LB. Freehand real-time elastography: impact of scanning parameters on image quality and in vitro intra- and interobserver validations. Ultrasound Med Biol. 2008 Oct;34(10):1638-50. doi: 10.1016/j.ultrasmedbio.2008.03.009. Epub 2008 Jun 4.
- Background: PubMed 21437851Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J, Arcidiacono P, Will U, Giovannini M, Dietrich C, Havre R, Gheorghe C, McKay C, Gheonea DI, Ciurea T; European EUS Elastography Multicentric Study Group. Accuracy of endoscopic ultrasound elastography used for differential diagnosis of focal pancreatic masses: a multicenter study. Endoscopy. 2011 Jul;43(7):596-603. doi: 10.1055/s-0030-1256314. Epub 2011 Mar 24.
- Background: PubMed 21667433Havre RF, Waage JR, Gilja OH, Odegaard S, Nesje LB. Real-Time Elastography: Strain Ratio Measurements Are Influenced by the Position of the Reference Area. Ultraschall Med. 2012 Dec;33(6):559-568. doi: 10.1055/s-0031-1273247. Epub 2011 Jun 10.
- Results publication: PubMed 21963957Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J, Arcidiacono P, Will U, Giovannini M, Dietrich CF, Havre R, Gheorghe C, McKay C, Gheonea DI, Ciurea T; European EUS Elastography Multicentric Study Group. Efficacy of an artificial neural network-based approach to endoscopic ultrasound elastography in diagnosis of focal pancreatic masses. Clin Gastroenterol Hepatol. 2012 Jan;10(1):84-90.e1. doi: 10.1016/j.cgh.2011.09.014. Epub 2011 Oct 1.
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.
Lars Birger Nesje, MD, PhD study director
University of Bergen
Roald F. Havre, MD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Upper Gastrointestinal Tract and Pancreatic Nodule, run by Haukeland University Hospital at 1 site in Norway.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Sep 2012. 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 Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Malignant or benign lesion (time frame: Jan 2007 - September 2011 + 6 months( if no tissue sample)(4 years)). 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 NCT01360411, which also lists 5 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 5 Sep 2012; AzTrials last refreshed its copy on 27 Oct 2026.