Esophageal NeoplasmsNCT04622098
Prevalence of Sub-epithelial Lesions Among Patients Undergoing EGDs in Egypt
An observational study of Esophageal Neoplasms and Gastric Neoplasm, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Subepithelial lesions (SEL) are incidentally observed in the stomach of about 0.3% of middle-aged men and women; half of these are neoplastic. The incidence of subepithelial tumors (SET) of gastrointestinal (GI) origin has risen twofold to fivefold within the past 30 years.The etiology of most SMTs cannot easily be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms, Gastric Neoplasm, Duodenal Neoplasms
- What is being tested?
- Endoscopic ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Nov 2020to Jan 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients presented to endoscopy units participating in the study and in need for upper endoscopy will be given informed written consent to participate in the study. Possible complications will be described clearly to the patients before the endoscopic procedure. Complete medical history will be recorded specially symptoms suggesting GIT bleeding as hematemesis, melena, or manifestations of anemia. Symptoms suggesting malignancy as weight loss, anorexia, history of previous malignancies will be recorded. Past history of endoscopic procedures, of having previous GIT troubles and of any chronic medical illness or medications will be recorded. Vital signs will be taken for the patients before beginning the endoscopic procedure and after being evaluated by an anesthetist.
Who may be able to join
- Any patient with detected sub-epithelial lesion during upper endoscopy either symptomatized or accidently discovered.
- Patients diagnosed by EUS, CT scan or surgically removed lesions.
Who cannot join
- Patients missing follow up to reach a sure diagnosis for the lesions.
- Patients unfit for endoscopic procedures.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 33565
Mariam S Zaghloul, MD, 01006896422, mariam_zaghloul@med.kfs.edu.eg
About this study
Subepithelial lesions (SEL) are incidentally observed in the stomach of about 0.3% of middle-aged men and women; half of these are neoplastic. The incidence of subepithelial tumors (SET) of gastrointestinal (GI) origin has risen twofold to fivefold within the past 30 years.The etiology of most SMTs cannot easily be determined by endoscopy. So, we aim to estimate the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt.
Read the detailed description
Worldwide, the gastrointestinal (GI) tract is the organ system with the highest cancer incidence (20.5% of all new cases) and annual mortality (22% = 1.81 Mio). Early endoscopic detection and resection has led to improved survival rates for colorectal and gastric cancer, especially for gastric cancer in Japan, where more than 70% are now detected as early gastric cancer. Subepithelial lesions (SELs) of the GI tract are tumors that originate from the muscularis mucosa, submucosa, or muscularis propria. The term subepithelial lesion is preferred to the term submucosal tumor, which should be reserved for those that originate from the submucosal layer. SELs are most commonly found in the stomach, as often as 1 in every 300 endoscopies. The majority of these tumors are benign, with fewer than 15% found to be malignant at presentation.
Subepithelial lesions (SEL) are incidentally observed in the stomach of about 0.3% of middle-aged men and women; half of these are neoplastic. The incidence of subepithelial tumors (SET) of gastrointestinal (GI) origin has risen twofold to fivefold within the past 30 years.
According to the Korea EUS Study Group (unpublished data), the prevalence of gastric SETs, detected routine esophagogastroduodenoscopy, in Korea is 3.1%.
The etiology of most SMTs cannot easily be determined by endoscopy. Subepithelial lesions are those located beneath the epithelium and originate from any layer of the gastrointestinal wall. EUS is the best imaging modality to assess gastrointestinal subepithelial lesions and can be used for EUS guided tissue sampling, in addition to diagnostic imaging of the nodule. It helps to distinguish extrinsic lesions from intramural ones based on the originating layer, echogenicity and tissue acquisition to reach an accurate diagnosis. In clinical practice, cytological and immunocytochemical results determine the final diagnosis. EUS is superior to other imaging modalities (CT, magnetic resonance imaging) in characterizing small (<2 cm) lesions.
NCCN guideline on GISTs recommends resection of all symptomatic lesions, any lesions that are ≥2 cm, or lesions that have high risk features under EUS. Annual surveillance is recommended for low risk GISTs. Neuroendocrine tumours (NET) , meanwhile, has higher malignant potentials. Some investigators advocate resecting all visible lesions. The minimal approach should be to resect tumors ≥1 cm in diameter. NET require surveillance similar if not more stringent than GIST.
Endoscopic mucosal forceps biopsy is the standard procedures for establishing diagnoses in patients with GI tumors. However, the false negative rate of endoscopic mucosal forceps biopsy can be as high as 50%. Possible reasons for this false negative rate include infiltrative and stenotic diseases as well as lesions in submucosal locations, such as lymphoma.
Because of their subepithelial location, biopsies with endoscopic forceps often fail to provide diagnostic tissues. Thus, further imaging and sampling techniques (often with EUS) often are used to characterize these lesions especially in large lesions.
Study objectives:
- Primary Objectives: Estimating the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt.
- Secondary objectives:
Determining the real predominance of sub-epithelial lesions considering sex and age differences.
Investigating the geographic distribution in relation to the diagnosis of the lesions.
Detecting the commonest sites for the sub-epithelial lesions. Recording the symptomology related to each type.
- Conditions
- Esophageal Neoplasms, Gastric Neoplasm, Duodenal Neoplasms
- Being tested
- Endoscopic ultrasound
- Keywords
- sub-epithelial lesions, esophagogastrodudenoscopy, EUS FNA/FNB
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Duodenal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasoundProcedure or surgery
Also called CT
this is an endoscopic procedure for the assessment of the lesions, the following will be recorded:
- the tumor location,
- layer of origin,
- maximal diameter,
- regularity of extraluminal border,
- echopattern,
- presence of cystic spaces or echogenic foci.
| Study group | Role | What they receive |
|---|---|---|
| patients with SEL | Any patient with detected sub-epithelial lesion during upper endoscopy either symptomatized or accidently discovered.
Patients diagnosed by EUS, CT scan or surgically removed lesions. Receives: Procedure: Endoscopic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimating the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt.
prevalence rate
Measured: 6 months
Secondary outcomes (1)
characterization of SEL in Egypt
correlation to demographic data
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start18 Nov 2020
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University Hospital, Menoufia University, Al-Azhar University, Assiut University
- Responsible party
- Principal investigator, Mariam Salah Zaghloul, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622098
- Sponsor's protocol ID
- 135/2020
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwang JH, Rulyak SD, Kimmey MB; American Gastroenterological Association Institute. American Gastroenterological Association Institute technical review on the management of gastric subepithelial masses. Gastroenterology. 2006 Jun;130(7):2217-28. doi: 10.1053/j.gastro.2006.04.033.
PubMed 16762644Standards of Practice Committee; Faulx AL, Kothari S, Acosta RD, Agrawal D, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Gurudu SR, Khashab MA, Lightdale JR, Muthusamy VR, Shaukat A, Qumseya BJ, Wang A, Wani SB, Yang J, DeWitt JM. The role of endoscopy in subepithelial lesions of the GI tract. Gastrointest Endosc. 2017 Jun;85(6):1117-1132. doi: 10.1016/j.gie.2017.02.022. Epub 2017 Apr 3. No abstract available.
PubMed 28385194Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PubMed 25220842Papanikolaou IS, Triantafyllou K, Kourikou A, Rosch T. Endoscopic ultrasonography for gastric submucosal lesions. World J Gastrointest Endosc. 2011 May 16;3(5):86-94. doi: 10.4253/wjge.v3.i5.86.
PubMed 21772939Polkowski M. Endoscopic ultrasound and endoscopic ultrasound-guided fine-needle biopsy for the diagnosis of malignant submucosal tumors. Endoscopy. 2005 Jul;37(7):635-45. doi: 10.1055/s-2005-861422. No abstract available.
PubMed 16010608Hedenbro JL, Ekelund M, Wetterberg P. Endoscopic diagnosis of submucosal gastric lesions. The results after routine endoscopy. Surg Endosc. 1991;5(1):20-3. doi: 10.1007/BF00591381.
PubMed 1871670Nishida T, Kawai N, Yamaguchi S, Nishida Y. Submucosal tumors: comprehensive guide for the diagnosis and therapy of gastrointestinal submucosal tumors. Dig Endosc. 2013 Sep;25(5):479-89. doi: 10.1111/den.12149. Epub 2013 Jul 31.
PubMed 23902569Wiech T, Walch A, Werner M. Histopathological classification of nonneoplastic and neoplastic gastrointestinal submucosal lesions. Endoscopy. 2005 Jul;37(7):630-4. doi: 10.1055/s-2005-870127.
PubMed 16010607Park EY, Kim GH. Diagnosis of Gastric Subepithelial Tumors Using Endoscopic Ultrasonography or Abdominopelvic Computed Tomography: Which is Better? Clin Endosc. 2019 Nov;52(6):519-520. doi: 10.5946/ce.2019.188. Epub 2019 Nov 14. No abstract available.
PubMed 31722518Mathew, Madhu MD1; Mbachi, Chimezie MD1; Desai, Parth M. DO1; Salazar, Miguel MD2; Vohra, Ishaan MD1; Wang, Yuchen MD2; Gandhi, Seema MD3; Attar, Bashar M. MD, PhD1 2893 Epidemiology of Sub-Epithelial Gastrointestinal Lesions and Factors Influencing Their Tissue Yield by EUS Guided Sampling in a Predominantly African-American and Hispanic Population at a Tertiary Care County Hospital, The American Journal of Gastroenterology: October 2019 - Volume 114 - Issue - p S1584 doi: 10.14309/01.ajg.0000601104.52032.6f
Okten RS, Kacar S, Kucukay F, Sasmaz N, Cumhur T. Gastric subepithelial masses: evaluation of multidetector CT (multiplanar reconstruction and virtual gastroscopy) versus endoscopic ultrasonography. Abdom Imaging. 2012 Aug;37(4):519-30. doi: 10.1007/s00261-011-9791-0.
PubMed 21822967Demetri GD, von Mehren M, Antonescu CR, DeMatteo RP, Ganjoo KN, Maki RG, Pisters PW, Raut CP, Riedel RF, Schuetze S, Sundar HM, Trent JC, Wayne JD. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw. 2010 Apr;8 Suppl 2(0 2):S1-41; quiz S42-4. doi: 10.6004/jnccn.2010.0116.
PubMed 20457867Delle Fave G, O'Toole D, Sundin A, Taal B, Ferolla P, Ramage JK, Ferone D, Ito T, Weber W, Zheng-Pei Z, De Herder WW, Pascher A, Ruszniewski P; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Gastroduodenal Neuroendocrine Neoplasms. Neuroendocrinology. 2016;103(2):119-24. doi: 10.1159/000443168. Epub 2016 Jan 19. No abstract available.
PubMed 26784901Ramage JK, De Herder WW, Delle Fave G, Ferolla P, Ferone D, Ito T, Ruszniewski P, Sundin A, Weber W, Zheng-Pei Z, Taal B, Pascher A; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Colorectal Neuroendocrine Neoplasms. Neuroendocrinology. 2016;103(2):139-43. doi: 10.1159/000443166. Epub 2016 Jan 5. No abstract available.
PubMed 26730835Palazzo L, Landi B, Cellier C, Cuillerier E, Roseau G, Barbier JP. Endosonographic features predictive of benign and malignant gastrointestinal stromal cell tumours. Gut. 2000 Jan;46(1):88-92. doi: 10.1136/gut.46.1.88.
PubMed 10601061
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sub-epithelial Lesions Among Patients Undergoing EGDs in Egypt
- ClinicalTrials.gov ID
- NCT04622098
- Acronym / sponsor ID
- 135/2020
- Conditions
- Esophageal Neoplasms, Gastric Neoplasm, Duodenal Neoplasms
- Keywords
- sub-epithelial lesions, esophagogastrodudenoscopy, EUS FNA/FNB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Collaborators
- Mansoura University Hospital, Menoufia University, Al-Azhar University, Assiut University
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 9 Nov 2020 (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.
Subepithelial lesions (SEL) are incidentally observed in the stomach of about 0.3% of middle-aged men and women; half of these are neoplastic. The incidence of subepithelial tumors (SET) of gastrointestinal (GI) origin has risen twofold to fivefold within the past 30 years.The etiology of most SMTs cannot easily be determined by endoscopy. So, we aim to estimate the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt.
Detailed description
Worldwide, the gastrointestinal (GI) tract is the organ system with the highest cancer incidence (20.5% of all new cases) and annual mortality (22% = 1.81 Mio). Early endoscopic detection and resection has led to improved survival rates for colorectal and gastric cancer, especially for gastric cancer in Japan, where more than 70% are now detected as early gastric cancer. Subepithelial lesions (SELs) of the GI tract are tumors that originate from the muscularis mucosa, submucosa, or muscularis propria. The term subepithelial lesion is preferred to the term submucosal tumor, which should be reserved for those that originate from the submucosal layer. SELs are most commonly found in the stomach, as often as 1 in every 300 endoscopies. The majority of these tumors are benign, with fewer than 15% found to be malignant at presentation.
Subepithelial lesions (SEL) are incidentally observed in the stomach of about 0.3% of middle-aged men and women; half of these are neoplastic. The incidence of subepithelial tumors (SET) of gastrointestinal (GI) origin has risen twofold to fivefold within the past 30 years.
According to the Korea EUS Study Group (unpublished data), the prevalence of gastric SETs, detected routine esophagogastroduodenoscopy, in Korea is 3.1%.
The etiology of most SMTs cannot easily be determined by endoscopy. Subepithelial lesions are those located beneath the epithelium and originate from any layer of the gastrointestinal wall. EUS is the best imaging modality to assess gastrointestinal subepithelial lesions and can be used for EUS guided tissue sampling, in addition to diagnostic imaging of the nodule. It helps to distinguish extrinsic lesions from intramural ones based on the originating layer, echogenicity and tissue acquisition to reach an accurate diagnosis. In clinical practice, cytological and immunocytochemical results determine the final diagnosis. EUS is superior to other imaging modalities (CT, magnetic resonance imaging) in characterizing small (<2 cm) lesions.
NCCN guideline on GISTs recommends resection of all symptomatic lesions, any lesions that are ≥2 cm, or lesions that have high risk features under EUS. Annual surveillance is recommended for low risk GISTs. Neuroendocrine tumours (NET) , meanwhile, has higher malignant potentials. Some investigators advocate resecting all visible lesions. The minimal approach should be to resect tumors ≥1 cm in diameter. NET require surveillance similar if not more stringent than GIST.
Endoscopic mucosal forceps biopsy is the standard procedures for establishing diagnoses in patients with GI tumors. However, the false negative rate of endoscopic mucosal forceps biopsy can be as high as 50%. Possible reasons for this false negative rate include infiltrative and stenotic diseases as well as lesions in submucosal locations, such as lymphoma.
Because of their subepithelial location, biopsies with endoscopic forceps often fail to provide diagnostic tissues. Thus, further imaging and sampling techniques (often with EUS) often are used to characterize these lesions especially in large lesions.
Study objectives:
- Primary Objectives: Estimating the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt.
- Secondary objectives:
Determining the real predominance of sub-epithelial lesions considering sex and age differences.
Investigating the geographic distribution in relation to the diagnosis of the lesions.
Detecting the commonest sites for the sub-epithelial lesions. Recording the symptomology related to each type.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with SEL | – | Procedure: Endoscopic ultrasoundAny patient with detected sub-epithelial lesion during upper endoscopy either symptomatized or accidently discovered. Patients diagnosed by EUS, CT scan or surgically removed lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients presented to endoscopy units participating in the study and in need for upper endoscopy will be given informed written consent to participate in the study. Possible complications will be described clearly to the patients before the endoscopic procedure. Complete medical history will be recorded specially symptoms suggesting GIT bleeding as hematemesis, melena, or manifestations of anemia. Symptoms suggesting malignancy as weight loss, anorexia, history of previous malignancies will be recorded. Past history of endoscopic procedures, of having previous GIT troubles and of any chronic medical illness or medications will be recorded. Vital signs will be taken for the patients before beginning the endoscopic procedure and after being evaluated by an anesthetist.
Key inclusion criteria (2 listed)
- Any patient with detected sub-epithelial lesion during upper endoscopy either symptomatized or accidently discovered.
- Patients diagnosed by EUS, CT scan or surgically removed lesions.
Key exclusion criteria (2 listed)
- Patients missing follow up to reach a sure diagnosis for the lesions.
- Patients unfit for endoscopic procedures.
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 |
|---|---|---|
| Endoscopic ultrasoundAlso: CTthis is an endoscopic procedure for the assessment of the lesions, the following will be recorded: 1. the tumor location, 2. layer of origin, 3. maximal diameter, 4. regularity of extraluminal border, 5. echopattern, 6. presence of cystic spaces or echogenic foci. | Procedure or surgery | patients with SEL |
Primary outcome
Estimating the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt.
Time frame: 6 months
prevalence rate
1 secondary outcome
characterization of SEL in Egypt
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Results publication: PubMed 16762644Hwang JH, Rulyak SD, Kimmey MB; American Gastroenterological Association Institute. American Gastroenterological Association Institute technical review on the management of gastric subepithelial masses. Gastroenterology. 2006 Jun;130(7):2217-28. doi: 10.1053/j.gastro.2006.04.033.
- Results publication: PubMed 28385194Standards of Practice Committee; Faulx AL, Kothari S, Acosta RD, Agrawal D, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Gurudu SR, Khashab MA, Lightdale JR, Muthusamy VR, Shaukat A, Qumseya BJ, Wang A, Wani SB, Yang J, DeWitt JM. The role of endoscopy in subepithelial lesions of the GI tract. Gastrointest Endosc. 2017 Jun;85(6):1117-1132. doi: 10.1016/j.gie.2017.02.022. Epub 2017 Apr 3. No abstract available.
- Results publication: PubMed 25220842Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
- Results publication: PubMed 21772939Papanikolaou IS, Triantafyllou K, Kourikou A, Rosch T. Endoscopic ultrasonography for gastric submucosal lesions. World J Gastrointest Endosc. 2011 May 16;3(5):86-94. doi: 10.4253/wjge.v3.i5.86.
- Results publication: PubMed 16010608Polkowski M. Endoscopic ultrasound and endoscopic ultrasound-guided fine-needle biopsy for the diagnosis of malignant submucosal tumors. Endoscopy. 2005 Jul;37(7):635-45. doi: 10.1055/s-2005-861422. No abstract available.
- Results publication: PubMed 1871670Hedenbro JL, Ekelund M, Wetterberg P. Endoscopic diagnosis of submucosal gastric lesions. The results after routine endoscopy. Surg Endosc. 1991;5(1):20-3. doi: 10.1007/BF00591381.
- Results publication: PubMed 23902569Nishida T, Kawai N, Yamaguchi S, Nishida Y. Submucosal tumors: comprehensive guide for the diagnosis and therapy of gastrointestinal submucosal tumors. Dig Endosc. 2013 Sep;25(5):479-89. doi: 10.1111/den.12149. Epub 2013 Jul 31.
- Results publication: PubMed 16010607Wiech T, Walch A, Werner M. Histopathological classification of nonneoplastic and neoplastic gastrointestinal submucosal lesions. Endoscopy. 2005 Jul;37(7):630-4. doi: 10.1055/s-2005-870127.
- Results publication: PubMed 31722518Park EY, Kim GH. Diagnosis of Gastric Subepithelial Tumors Using Endoscopic Ultrasonography or Abdominopelvic Computed Tomography: Which is Better? Clin Endosc. 2019 Nov;52(6):519-520. doi: 10.5946/ce.2019.188. Epub 2019 Nov 14. No abstract available.
- Results publicationMathew, Madhu MD1; Mbachi, Chimezie MD1; Desai, Parth M. DO1; Salazar, Miguel MD2; Vohra, Ishaan MD1; Wang, Yuchen MD2; Gandhi, Seema MD3; Attar, Bashar M. MD, PhD1 2893 Epidemiology of Sub-Epithelial Gastrointestinal Lesions and Factors Influencing Their Tissue Yield by EUS Guided Sampling in a Predominantly African-American and Hispanic Population at a Tertiary Care County Hospital, The American Journal of Gastroenterology: October 2019 - Volume 114 - Issue - p S1584 doi: 10.14309/01.ajg.0000601104.52032.6f
- Results publication: PubMed 21822967Okten RS, Kacar S, Kucukay F, Sasmaz N, Cumhur T. Gastric subepithelial masses: evaluation of multidetector CT (multiplanar reconstruction and virtual gastroscopy) versus endoscopic ultrasonography. Abdom Imaging. 2012 Aug;37(4):519-30. doi: 10.1007/s00261-011-9791-0.
- Results publication: PubMed 20457867Demetri GD, von Mehren M, Antonescu CR, DeMatteo RP, Ganjoo KN, Maki RG, Pisters PW, Raut CP, Riedel RF, Schuetze S, Sundar HM, Trent JC, Wayne JD. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw. 2010 Apr;8 Suppl 2(0 2):S1-41; quiz S42-4. doi: 10.6004/jnccn.2010.0116.
- 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.
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 Esophageal Neoplasms and Gastric Neoplasm, run by Kafrelsheikh University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Sep 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimating the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt. (time frame: 6 months). 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 NCT04622098, which also lists 16 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 1 Sep 2021.