Pancreatic CancerEchoSurgNCT04899739
Intraoperative Endoscopic Ultrasound for Pancreatic Cancer
A study testing Echoendoscopy in people with Pancreatic Cancer, run by IHU Strasbourg at 1 site in France.
Trial summary
Nowadays pancreatic cancer is one of the deadliest oncological pathologies. The only effective curative tool is the surgery. Before the intervention, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Echoendoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2021to 12 Nov 2025
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old
- Patient with a solid or degenerated cystic tumor of the pancreas requiring curative surgery
- Patient with a complete clinical examination performed
- Patient with no contraindication to anesthesia, upper digestive endoscopy and pancreatic surgery
- Patient able to receive and understand information relating to the study and give informed written consent
- Patient affiliated to the French social security system
Who cannot join
- Patient presenting with bleeding disease with disorder hemostasis and coagulation (PT <60%, TCA> 40 s and platelets <60,000 / mm3)
- Patient on anticoagulant or antiaggregant treatment that cannot be temporarily interrupted
- Patient carrying a right-left shunt, a severe pulmonary arterial hypertension (high blood pressure pulmonary> 90 mm Hg), uncontrolled systemic hypertension or suffering from respiratory distress syndrome.
- Pregnant or breastfeeding patient
- Patient in exclusion period (determined by a previous study or in progress)
- Patient under legal protection
- Patient under guardianship or trusteeship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Preoperative Diagnostic Endoscopy for the Diagnosis of Occult Metastatic Lesions of Operable Pancreatic Cancer
Nowadays pancreatic cancer is one of the deadliest oncological pathologies. The only effective curative tool is the surgery. Before the intervention, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. In this study, the echoendoscopie will be extended to lymph node staging away from the surgical field in order to implement a simple classification of lymph nodes, based on non-invasive ultrasound criteria. This would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.
Read the detailed description
Nowadays pancreatic cancer is one of the deadliest oncological pathologies today. Even after curative surgery, considered the only effective curative tool, 5-years survival does not exceed 5%. Before surgery, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. However, the evaluation being devoted to the pancreas, this study wishes to extend echoendoscopie to lymph node staging away from the surgical field. The proposed study is based on the hypothesis that the implementation of a simple classification of lymph nodes, based on non-invasive ultrasound criteria, would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.
At the same time, the video data obtained will be collected in a computer database in order to create an artificial intelligence lesion detection and qualification tool.
This study plans to recruit 45 adult patients, male or female, with a solid or cystic pancreatic tumor and for whom a surgical resection (first line and after neoadjuvant treatment) is planned. The main objective is to estimate the sensitivity and specificity of a simple classification "benign / malignant" of the nodes, established by the endoscopist using endoscopic ultrasound criteria's, compared to the gold standard (anatomopathology).
- Conditions
- Pancreatic Cancer
- Being tested
- Echoendoscopy
- Keywords
- EUS, Endoscopic Ultrasound, Biopsy, Pancreatic surgery, Pancreatic Cancer, Artificial intelligence
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoendoscopyDiagnostic test
Peripancreatic lymph nodes and at a distance from the pancreas assessment by endoscopic ultrasound, elastography an doppler to record their anatomical location and characteristics. All lymph nodes suspected of metastatic disease will be marked with sterile black ink.
| Study group | Role | What they receive |
|---|---|---|
| Peripancreatic and distant lymph node assessment | Experimental | All patients programmed for an endoscopic ultrasound in the context of a pancreatic cancer Receives: Diagnostic Test: Echoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of lymph nodes correctly categorised by ultrasound endoscopy. (Sensitivity)
Number of lymph nodes correctly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).
Measured: 1 month
Rate of lymph nodes wrongly categorised by ultrasound endoscopy. (Specificity)
Number of lymph nodes wrongly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).
Measured: 1 month
Secondary outcomes (11)
Rate of metastases actually diagnosed
Comparison between the number of suspected lymph nodes identified during preoperative endoscopic ultrasound and results of the histological analysis of these resected lymph nodes.
Measured: 1 month
Location of hidden lymph node metastases
Description of the location of hidden lymph node metastases identified by endoscopic ultrasound
Measured: 1 day
Number of distant nodes detected during the endoscopic ultrasound
Number of distant nodes detected during the preoperative endoscopic ultrasound
Measured: 1 day
Number of distant malignant lymph nodes
Number of distant lymph nodes detected during the preoperative endoscopic ultrasound and whose malignancy has been confirmed by the gold standard
Measured: 1 month
Rate of patients for whom contraindications for surgery has been detected during the endoscopic ultrasound
Number of patients for whom a contraindication to surgery has been detected during the endoscopic ultrasound, on the total number of patients included.
Measured: 1 day
Rate of patients for whom elastography was required to identify lymph node metastases hidden away from the surgical site
Number of patients for whom elastography was required to identify distant hidden lymph node metastases
Measured: 1 day
Measurement of the operating time required to perform preoperative elastography
Measurement of the operating time (in minutes) required to perform preoperative elastography.
Measured: 1 day
Measurement of the additional costs generated by materials required for preoperative elastography
Measurement of the additional costs (in euros) generated by materials required for preoperative elastography in resectable pancreas cancer patients
Measured: 1 day
Impact of sterile black ink marking of distant nodes during the preoperative EA
Analysis of the impact of sterile black ink marking of distant lymph nodes during preoperative ultrasound endoscopy on the surgical procedure by the mean of a questionnaire completed by the surgeon. This questionnaire will be assessed by a score of Likert varying between 1 (not satisfied) and 5 (very satisfied).
Measured: 1 day
Development of an algorithm capable of detecting lymph nodes metastases by the mean of artificial intelligence
Deep learning-based analysis of video data from the ultrasound endoscopy
Measured: 1 day
Development of an algorithm capable of characterizing lymph nodes metastases by the mean of artificial intelligence
Deep learning-based analysis of video data from the ultrasound endoscopy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start5 Dec 2021
- Primary completion4 Jun 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pancreatic 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Pessaux, MD, Principal investigator, Unité de Chirurgie Hépato-biliaire et Pancréatique, NHC Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899739
- Sponsor's protocol ID
- 18-007
- Acronym
- EchoSurg
- Status last verified
- Apr 2026
- First submitted
- 21 May 2021
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
PubMed 23335087Kleeff J, Reiser C, Hinz U, Bachmann J, Debus J, Jaeger D, Friess H, Buchler MW. Surgery for recurrent pancreatic ductal adenocarcinoma. Ann Surg. 2007 Apr;245(4):566-72. doi: 10.1097/01.sla.0000245845.06772.7d.
PubMed 17414605Poruk KE, Firpo MA, Adler DG, Mulvihill SJ. Screening for pancreatic cancer: why, how, and who? Ann Surg. 2013 Jan;257(1):17-26. doi: 10.1097/SLA.0b013e31825ffbfb.
PubMed 22895395Butturini G, Stocken DD, Wente MN, Jeekel H, Klinkenbijl JH, Bakkevold KE, Takada T, Amano H, Dervenis C, Bassi C, Buchler MW, Neoptolemos JP; Pancreatic Cancer Meta-Analysis Group. Influence of resection margins and treatment on survival in patients with pancreatic cancer: meta-analysis of randomized controlled trials. Arch Surg. 2008 Jan;143(1):75-83; discussion 83. doi: 10.1001/archsurg.2007.17.
PubMed 18209156Galasso D, Carnuccio A, Larghi A. Pancreatic cancer: diagnosis and endoscopic staging. Eur Rev Med Pharmacol Sci. 2010 Apr;14(4):375-85.
PubMed 20496552Al-Haddad M, Wallace MB, Woodward TA, Gross SA, Hodgens CM, Toton RD, Raimondo M. The safety of fine-needle aspiration guided by endoscopic ultrasound: a prospective study. Endoscopy. 2008 Mar;40(3):204-8. doi: 10.1055/s-2007-995336. Epub 2007 Dec 4.
PubMed 18058615Bhutani MS, Hawes RH, Hoffman BJ. A comparison of the accuracy of echo features during endoscopic ultrasound (EUS) and EUS-guided fine-needle aspiration for diagnosis of malignant lymph node invasion. Gastrointest Endosc. 1997 Jun;45(6):474-9. doi: 10.1016/s0016-5107(97)70176-7.
PubMed 9199903Kanamori A, Hirooka Y, Itoh A, Hashimoto S, Kawashima H, Hara K, Uchida H, Goto J, Ohmiya N, Niwa Y, Goto H. Usefulness of contrast-enhanced endoscopic ultrasonography in the differentiation between malignant and benign lymphadenopathy. Am J Gastroenterol. 2006 Jan;101(1):45-51. doi: 10.1111/j.1572-0241.2006.00394.x.
PubMed 16405532Giovannini M, Thomas B, Erwan B, Christian P, Fabrice C, Benjamin E, Genevieve M, Paolo A, Pierre D, Robert Y, Walter S, Hanz S, Carl S, Christoph D, Pierre E, Jean-Luc VL, Jacques D, Peter V, Andrian S. Endoscopic ultrasound elastography for evaluation of lymph nodes and pancreatic masses: a multicenter study. World J Gastroenterol. 2009 Apr 7;15(13):1587-93. doi: 10.3748/wjg.15.1587.
PubMed 19340900Nawaz H, Fan CY, Kloke J, Khalid A, McGrath K, Landsittel D, Papachristou GI. Performance characteristics of endoscopic ultrasound in the staging of pancreatic cancer: a meta-analysis. JOP. 2013 Sep 10;14(5):484-97. doi: 10.6092/1590-8577/1512.
PubMed 24018593
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Preoperative Diagnostic Endoscopy for the Diagnosis of Occult Metastatic Lesions of Operable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04899739
- Acronym / sponsor ID
- EchoSurg / 18-007
- Conditions
- Pancreatic Cancer
- Keywords
- EUS, Endoscopic Ultrasound, Biopsy, Pancreatic surgery, Pancreatic Cancer, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 5 Dec 2021 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 24 May 2021 (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.
Nowadays pancreatic cancer is one of the deadliest oncological pathologies. The only effective curative tool is the surgery. Before the intervention, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. In this study, the echoendoscopie will be extended to lymph node staging away from the surgical field in order to implement a simple classification of lymph nodes, based on non-invasive ultrasound criteria. This would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.
Detailed description
Nowadays pancreatic cancer is one of the deadliest oncological pathologies today. Even after curative surgery, considered the only effective curative tool, 5-years survival does not exceed 5%. Before surgery, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. However, the evaluation being devoted to the pancreas, this study wishes to extend echoendoscopie to lymph node staging away from the surgical field. The proposed study is based on the hypothesis that the implementation of a simple classification of lymph nodes, based on non-invasive ultrasound criteria, would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.
At the same time, the video data obtained will be collected in a computer database in order to create an artificial intelligence lesion detection and qualification tool.
This study plans to recruit 45 adult patients, male or female, with a solid or cystic pancreatic tumor and for whom a surgical resection (first line and after neoadjuvant treatment) is planned. The main objective is to estimate the sensitivity and specificity of a simple classification "benign / malignant" of the nodes, established by the endoscopist using endoscopic ultrasound criteria's, compared to the gold standard (anatomopathology).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripancreatic and distant lymph node assessment | Experimental | Diagnostic Test: EchoendoscopyAll patients programmed for an endoscopic ultrasound in the context of a pancreatic cancer |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient over 18 years old
- Patient with a solid or degenerated cystic tumor of the pancreas requiring curative surgery
- Patient with a complete clinical examination performed
- Patient with no contraindication to anesthesia, upper digestive endoscopy and pancreatic surgery
- Patient able to receive and understand information relating to the study and give informed written consent
Key exclusion criteria (7 listed)
- Patient presenting with bleeding disease with disorder hemostasis and coagulation (PT <60%, TCA> 40 s and platelets <60,000 / mm3)
- Patient on anticoagulant or antiaggregant treatment that cannot be temporarily interrupted
- Patient carrying a right-left shunt, a severe pulmonary arterial hypertension (high blood pressure pulmonary> 90 mm Hg), uncontrolled systemic hypertension or suffering from respiratory distress syndrome.
- Pregnant or breastfeeding patient
- Patient in exclusion period (determined by a previous study or in progress)
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 |
|---|---|---|
| EchoendoscopyPeripancreatic lymph nodes and at a distance from the pancreas assessment by endoscopic ultrasound, elastography an doppler to record their anatomical location and characteristics. All lymph nodes suspected of metastatic disease will be marked with sterile black ink. | Diagnostic test | Peripancreatic and distant lymph node assessment |
Primary outcome
Rate of lymph nodes correctly categorised by ultrasound endoscopy. (Sensitivity)
Time frame: 1 month
Number of lymph nodes correctly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).
Rate of lymph nodes wrongly categorised by ultrasound endoscopy. (Specificity)
Time frame: 1 month
Number of lymph nodes wrongly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).
11 secondary outcomes
Rate of metastases actually diagnosed
Time frame: 1 month
Location of hidden lymph node metastases
Time frame: 1 day
Number of distant nodes detected during the endoscopic ultrasound
Time frame: 1 day
Number of distant malignant lymph nodes
Time frame: 1 month
Rate of patients for whom contraindications for surgery has been detected during the endoscopic ultrasound
Time frame: 1 day
Rate of patients for whom elastography was required to identify lymph node metastases hidden away from the surgical site
Time frame: 1 day
Measurement of the operating time required to perform preoperative elastography
Time frame: 1 day
Measurement of the additional costs generated by materials required for preoperative elastography
Time frame: 1 day
Impact of sterile black ink marking of distant nodes during the preoperative EA
Time frame: 1 day
Development of an algorithm capable of detecting lymph nodes metastases by the mean of artificial intelligence
Time frame: 1 day
Development of an algorithm capable of characterizing lymph nodes metastases by the mean of artificial intelligence
Time frame: 1 day
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 17 Apr 2026.
- Background: PubMed 23335087Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
- Background: PubMed 17414605Kleeff J, Reiser C, Hinz U, Bachmann J, Debus J, Jaeger D, Friess H, Buchler MW. Surgery for recurrent pancreatic ductal adenocarcinoma. Ann Surg. 2007 Apr;245(4):566-72. doi: 10.1097/01.sla.0000245845.06772.7d.
- Background: PubMed 22895395Poruk KE, Firpo MA, Adler DG, Mulvihill SJ. Screening for pancreatic cancer: why, how, and who? Ann Surg. 2013 Jan;257(1):17-26. doi: 10.1097/SLA.0b013e31825ffbfb.
- Background: PubMed 18209156Butturini G, Stocken DD, Wente MN, Jeekel H, Klinkenbijl JH, Bakkevold KE, Takada T, Amano H, Dervenis C, Bassi C, Buchler MW, Neoptolemos JP; Pancreatic Cancer Meta-Analysis Group. Influence of resection margins and treatment on survival in patients with pancreatic cancer: meta-analysis of randomized controlled trials. Arch Surg. 2008 Jan;143(1):75-83; discussion 83. doi: 10.1001/archsurg.2007.17.
- Background: PubMed 20496552Galasso D, Carnuccio A, Larghi A. Pancreatic cancer: diagnosis and endoscopic staging. Eur Rev Med Pharmacol Sci. 2010 Apr;14(4):375-85.
- Background: PubMed 18058615Al-Haddad M, Wallace MB, Woodward TA, Gross SA, Hodgens CM, Toton RD, Raimondo M. The safety of fine-needle aspiration guided by endoscopic ultrasound: a prospective study. Endoscopy. 2008 Mar;40(3):204-8. doi: 10.1055/s-2007-995336. Epub 2007 Dec 4.
- Background: PubMed 9199903Bhutani MS, Hawes RH, Hoffman BJ. A comparison of the accuracy of echo features during endoscopic ultrasound (EUS) and EUS-guided fine-needle aspiration for diagnosis of malignant lymph node invasion. Gastrointest Endosc. 1997 Jun;45(6):474-9. doi: 10.1016/s0016-5107(97)70176-7.
- Background: PubMed 16405532Kanamori A, Hirooka Y, Itoh A, Hashimoto S, Kawashima H, Hara K, Uchida H, Goto J, Ohmiya N, Niwa Y, Goto H. Usefulness of contrast-enhanced endoscopic ultrasonography in the differentiation between malignant and benign lymphadenopathy. Am J Gastroenterol. 2006 Jan;101(1):45-51. doi: 10.1111/j.1572-0241.2006.00394.x.
- Background: PubMed 19340900Giovannini M, Thomas B, Erwan B, Christian P, Fabrice C, Benjamin E, Genevieve M, Paolo A, Pierre D, Robert Y, Walter S, Hanz S, Carl S, Christoph D, Pierre E, Jean-Luc VL, Jacques D, Peter V, Andrian S. Endoscopic ultrasound elastography for evaluation of lymph nodes and pancreatic masses: a multicenter study. World J Gastroenterol. 2009 Apr 7;15(13):1587-93. doi: 10.3748/wjg.15.1587.
- Background: PubMed 24018593Nawaz H, Fan CY, Kloke J, Khalid A, McGrath K, Landsittel D, Papachristou GI. Performance characteristics of endoscopic ultrasound in the staging of pancreatic cancer: a meta-analysis. JOP. 2013 Sep 10;14(5):484-97. doi: 10.6092/1590-8577/1512.
- 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.
Patrick Pessaux, MD principal investigator
Unité de Chirurgie Hépato-biliaire et Pancréatique, NHC 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 Echoendoscopy in people with Pancreatic 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 6 inclusion and 7 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 17 Apr 2026. 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 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?
Rate of lymph nodes correctly categorised by ultrasound endoscopy. (Sensitivity) (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT04899739, which also lists 10 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 17 Apr 2026.