Intraoperative Endoscopic Ultrasound for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— EchoSurg  

Official title:

Prospective Study of Preoperative Diagnostic Endoscopy for the Diagnosis of Occult Metastatic Lesions of Operable Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04899739
• Other study ID #: 18-007
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2021
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: IHU Strasbourg
• Contact: Armelle TAKEDA, PhD
• Phone: 0390413608
• Email: armelle.takeda[@]ihu-strasbourg.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

1. Patient over 18 years old

2. Patient with a solid or degenerated cystic tumor of the pancreas requiring curative surgery

3. Patient with a complete clinical examination performed

4. Patient with no contraindication to anesthesia, upper digestive endoscopy and pancreatic surgery

5. Patient able to receive and understand information relating to the study and give informed written consent

6. Patient affiliated to the French social security system

Exclusion Criteria:

1. Patient presenting with bleeding disease with disorder hemostasis and coagulation (PT <60%, TCA> 40 s and platelets <60,000 / mm3)

2. Patient on anticoagulant or antiaggregant treatment that cannot be temporarily interrupted

3. 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.

4. Pregnant or breastfeeding patient

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

6. Patient under legal protection

7. Patient under guardianship or trusteeship

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• Echoendoscopy
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.

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et Endocrinienne	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (10)

Al-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. — View Citation

Bhutani 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. — View Citation

Butturini 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. — View Citation

Galasso D, Carnuccio A, Larghi A. Pancreatic cancer: diagnosis and endoscopic staging. Eur Rev Med Pharmacol Sci. 2010 Apr;14(4):375-85. — View Citation

Giovannini 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. — View Citation

Kanamori 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. — View Citation

Kleeff 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. — View Citation

Nawaz 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. — View Citation

Poruk 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 month
Primary	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).	1 month
Secondary	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.	1 month
Secondary	Location of hidden lymph node metastases	Description of the location of hidden lymph node metastases identified by endoscopic ultrasound	1 day
Secondary	Number of distant nodes detected during the endoscopic ultrasound	Number of distant nodes detected during the preoperative endoscopic ultrasound	1 day
Secondary	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	1 month
Secondary	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.	1 day
Secondary	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	1 day
Secondary	Measurement of the operating time required to perform preoperative elastography	Measurement of the operating time (in minutes) required to perform preoperative elastography.	1 day
Secondary	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	1 day
Secondary	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).	1 day
Secondary	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	1 day
Secondary	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	1 day