Intestinal Ultrasound Versus Double Balloon Enteroscopy (DBE) in Diagnosis of Malabsorption Syndrome

NCT04777682 | Unknown

• 1 other identifier: U.S V.S DBE in malabsorption
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Our aim is to compare between intestinal ultrasound and double-balloon enteroscopy in the diagnosis of malabsorption syndrome.

Conditions

Malabsorption Syndrome

Outcome Measures

Primary Outcomes (1)

• Intestinal Ultrasound Versus Double Balloon Enteroscopy (DBE) in Diagnosis of Malabsorption Syndrome

  compare between intestinal ultrasound and double balloon enteroscopy in the diagnosis of malabsorption syndrome.

  two years

Study Arms (1)

single arm

OTHER

A single-arm, open, single-center (hospital-based) prospective interventional study to compare intestinal ultrasound versus double balloon enteroscopy in diagnosis of malabsorption syndrome

Procedure: ultrasound, double balloon enteroscopy

Interventions

ultrasound, double balloon enteroscopy PROCEDURE

compare intestinal ultrasound versus double-balloon enteroscopy in diagnosis of malabsorption syndrome

single arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Our study will include all patients referred to our unit with suspected malabsorption syndrome with one or more of the following will be included:
• Clinically:
• Chronic watery, diurnal, and nocturnal, bulky, and frequent diarrhea.
• Steatorrhea.
• Abdominal pain and /or distention.
• Anorexia, nausea, vomiting.
• Weight loss.
• Anemic manifestations
• Vitamin deficiencies manifestations (e.g Bleeding, bruising, glossitis Peripheral neuropathy) Malnutrition and growth retardation in children.
• Extraintestinal manifestations (e.g Dermatitis herpetiformis, Ankylosing spondylitis, erythema nodosum).
• Laboratory: routine blood tests that may reveal anemia, high CRP or low albumin, low calcium, and vitamin D level, high fecal calprotectin.

You may not qualify if:

• Mechanical gastrointestinal obstruction.
• Pregnant ladies.
• Those who fail to provide consent.
• Those unfit for anesthesia (with cardio-pulmonary embarrassment )

Sponsors & Collaborators

• Assiut University: lead

Related Publications (18)

• Ching HL, McAlindon ME, Sidhu R. An update on small bowel endoscopy. Curr Opin Gastroenterol. 2017 May;33(3):181-188. doi: 10.1097/MOG.0000000000000346.

  PMID: 28212152 BACKGROUND

• Ferro SM de, Correia JM, Pereira AD, Chavez P, Casaca R, Leitão CN. Divertículo de Meckel: diagnóstico por enteroscopia de duplo balão. 2010; 17: 65 - 8.

  BACKGROUND

• Gurkan OE, Karakan T, Dogan I, Dalgic B, Unal S. Comparison of double balloon enteroscopy in adults and children. World J Gastroenterol. 2013 Aug 7;19(29):4726-31. doi: 10.3748/wjg.v19.i29.4726.

  PMID: 23922469 BACKGROUND

• Jeon SR, Kim JO. Deep enteroscopy: which technique will survive? Clin Endosc. 2013 Sep;46(5):480-5. doi: 10.5946/ce.2013.46.5.480. Epub 2013 Sep 30.

  PMID: 24143307 BACKGROUND

• Keller J, Layer P. The Pathophysiology of Malabsorption. Viszeralmedizin. 2014 Jun;30(3):150-4. doi: 10.1159/000364794.

  PMID: 26288588 BACKGROUND

• Xin L, Liao Z, Jiang YP, Li ZS. Indications, detectability, positive findings, total enteroscopy, and complications of diagnostic double-balloon endoscopy: a systematic review of data over the first decade of use. Gastrointest Endosc. 2011 Sep;74(3):563-70. doi: 10.1016/j.gie.2011.03.1239. Epub 2011 May 28.

  PMID: 21620401 BACKGROUND

• Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.

  PMID: 19136102 BACKGROUND

• Nikaki K, Gupte GL. Assessment of intestinal malabsorption. Best Pract Res Clin Gastroenterol. 2016 Apr;30(2):225-35. doi: 10.1016/j.bpg.2016.03.003. Epub 2016 Mar 8.

  PMID: 27086887 BACKGROUND

• Nylund K, Odegaard S, Hausken T, Folvik G, Lied GA, Viola I, Hauser H, Gilja OH. Sonography of the small intestine. World J Gastroenterol. 2009 Mar 21;15(11):1319-30. doi: 10.3748/wjg.15.1319.

  PMID: 19294761 BACKGROUND

• Panes J, Bouhnik Y, Reinisch W, Stoker J, Taylor SA, Baumgart DC, Danese S, Halligan S, Marincek B, Matos C, Peyrin-Biroulet L, Rimola J, Rogler G, van Assche G, Ardizzone S, Ba-Ssalamah A, Bali MA, Bellini D, Biancone L, Castiglione F, Ehehalt R, Grassi R, Kucharzik T, Maccioni F, Maconi G, Magro F, Martin-Comin J, Morana G, Pendse D, Sebastian S, Signore A, Tolan D, Tielbeek JA, Weishaupt D, Wiarda B, Laghi A. Imaging techniques for assessment of inflammatory bowel disease: joint ECCO and ESGAR evidence-based consensus guidelines. J Crohns Colitis. 2013 Aug;7(7):556-85. doi: 10.1016/j.crohns.2013.02.020. Epub 2013 Apr 11.

  PMID: 23583097 BACKGROUND

• Pata C, Akyuz U, Erzin Y, Mercan A. Double-balloon enteroscopy: the diagnosis and management of small bowel diseases. Turk J Gastroenterol. 2010 Dec;21(4):353-9. doi: 10.4318/tjg.2010.0120.

  PMID: 21331987 BACKGROUND

• Prachayakul V, Deesomsak M, Aswakul P, Leelakusolvong S. The utility of single-balloon enteroscopy for the diagnosis and management of small bowel disorders according to their clinical manifestations: a retrospective review. BMC Gastroenterol. 2013 Jun 22;13:103. doi: 10.1186/1471-230X-13-103.

  PMID: 23800178 BACKGROUND

• Tan M, Lahiff C, Bassett P, Bailey AA, East JE. Efficacy of Balloon Overtube-Assisted Colonoscopy in Patients With Incomplete or Previous Difficult Colonoscopies: A Meta-analysis. Clin Gastroenterol Hepatol. 2017 Oct;15(10):1628-1630. doi: 10.1016/j.cgh.2017.04.023. Epub 2017 Apr 19. No abstract available.

  PMID: 28433783 BACKGROUND

• van der Heide F. Acquired causes of intestinal malabsorption. Best Pract Res Clin Gastroenterol. 2016 Apr;30(2):213-24. doi: 10.1016/j.bpg.2016.03.001. Epub 2016 Mar 8.

  PMID: 27086886 BACKGROUND

• Atkinson NSS, Bryant RV, Dong Y, Maaser C, Kucharzik T, Maconi G, Asthana AK, Blaivas M, Goudie A, Gilja OH, Nuernberg D, Schreiber-Dietrich D, Dietrich CF. How to perform gastrointestinal ultrasound: Anatomy and normal findings. World J Gastroenterol. 2017 Oct 14;23(38):6931-6941. doi: 10.3748/wjg.v23.i38.6931.

  PMID: 29097866 RESULT

• Beggs AD, Latchford AR, Vasen HF, Moslein G, Alonso A, Aretz S, Bertario L, Blanco I, Bulow S, Burn J, Capella G, Colas C, Friedl W, Moller P, Hes FJ, Jarvinen H, Mecklin JP, Nagengast FM, Parc Y, Phillips RK, Hyer W, Ponz de Leon M, Renkonen-Sinisalo L, Sampson JR, Stormorken A, Tejpar S, Thomas HJ, Wijnen JT, Clark SK, Hodgson SV. Peutz-Jeghers syndrome: a systematic review and recommendations for management. Gut. 2010 Jul;59(7):975-86. doi: 10.1136/gut.2009.198499.

  PMID: 20581245 RESULT

• Bryant RV, Friedman AB, Wright EK, Taylor KM, Begun J, Maconi G, Maaser C, Novak KL, Kucharzik T, Atkinson NSS, Asthana A, Gibson PR. Gastrointestinal ultrasound in inflammatory bowel disease: an underused resource with potential paradigm-changing application. Gut. 2018 May;67(5):973-985. doi: 10.1136/gutjnl-2017-315655. Epub 2018 Feb 3.

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• Cai JX, Diehl DL, Kiesslich R, Storm AC, El Zein MH, Tieu AH, Hoffman A, Singh VK, Khashab MA, Okolo PI 3rd, Kumbhari V. A multicenter experience of through-the-scope balloon-assisted enteroscopy in surgically altered gastrointestinal anatomy. Surg Endosc. 2017 Jul;31(7):2753-2762. doi: 10.1007/s00464-016-5282-2. Epub 2016 Dec 30.

  PMID: 28039647 RESULT

MeSH Terms

Conditions

Malabsorption Syndromes

Interventions

High-Energy Shock Waves; Double-Balloon Enteroscopy

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Balloon Enteroscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Laila Ab El-Touny, prof

  Assuit University, Egypt

  STUDY CHAIR

• Khaled Ab Khalaf, Dr

  Assuit University, Egypt

  STUDY DIRECTOR

• Sayed Ha Ahmed, Dr

  Assuit University, Egypt

  STUDY DIRECTOR

• Nada A Mahmoud, Dr

  Assuit University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nada A Mahmoud, Master

CONTACT

+201094056956; nadaabualnaga2018@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 2, 2021
• Study Start: June 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share