Evaluation of Capsule Colonoscopy in Patients With Lynch Syndrome

NCT07445828 | Not Yet Recruiting

• 1 other identifier: 2025-02563-01
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Lynch syndrome is the most common hereditary cancer syndrome and is caused by pathogenic variants in DNA mismatch repair genes, resulting in a markedly increased lifetime risk of colorectal cancer. The estimated lifetime risk of colorectal cancer varies by the affected gene and is approximately 54-74% in men and 30-52% in women with Lynch syndrome. Colorectal cancer in this population is typically diagnosed at a younger age than in the general population. Current national guidelines recommend colonoscopic surveillance every one to two years beginning at 20-25 years of age to reduce colorectal cancer risk. However, individualized modification of surveillance strategies is under active consideration based on factors such as the specific mutated gene, family history of cancer, smoking status, prior malignancies, and age at surveillance initiation. Conventional colonoscopy, the current standard method for colorectal evaluation, may cause substantial discomfort or anxiety, leading some patients to decline participation. Colonoscopy is also resource intensive, and procedural capacity is limited. Previously reported limitations in colonoscopy resources and quality in Sweden highlight the need to evaluate alternative surveillance and screening approaches. Colon capsule endoscopy (CCE) has been available for clinical use since 2006 as a non-invasive alternative to colonoscopy, enabling endoscopic visualization of the entire colon. The system consists of a single-use, swallowable capsule containing miniature cameras that capture images as the capsule progresses through the gastrointestinal tract via natural peristalsis. Images are transmitted wirelessly to a portable data recorder worn by the patient and subsequently reviewed using dedicated software. CCE offers several advantages compared with conventional colonoscopy and CT colonography, including no requirement for sedation, endoscope insertion, gas insufflation, or ionizing radiation. The examination and image acquisition can be performed outside the hospital setting. This patient-centered approach has the potential to improve adherence to repeated examinations and long-term surveillance programs, which is particularly important for individuals with hereditary colorectal cancer syndromes. CCE may also reduce demands on healthcare resources. International guidelines indicate that the mucosal diagnostic performance of CCE is comparable to that of standard colonoscopy and that the method is appropriate for screening purposes. Adequate bowel preparation is required for both colonoscopy and CCE. Unlike conventional colonoscopy, bowel cleansing cannot be optimized during CCE, and the procedure is limited by capsule battery life, typically 10-12 hours. To maintain bowel cleanliness and facilitate capsule transit, patients administer laxative and prokinetic agents at predefined time points during the examination. The primary objective of this study is to evaluate the diagnostic performance and safety of colon capsule endoscopy as a first-line surveillance modality in patients with Lynch syndrome and to assess patient experience and acceptance of CCE compared with conventional colonoscopy.

Conditions

Lynch Syndrome

Keywords

Lynch Syndrome; caspule colonoscopy

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance and safety of colon capsule endoscopy compared with conventional colonoscopy

  The primary outcome is the diagnostic yield and safety of colon capsule endoscopy (CCE) relative to conventional colonoscopy in patients with genetically confirmed Lynch syndrome. Diagnostic performance will be assessed by the detection of colonic lesions, including polyps, adenomas, and mucosal abnormalities, as evaluated by blinded review of both procedures. Safety will be assessed by recording all adverse events related to the procedure, including capsule retention, gastrointestinal symptoms, or other procedure-related complications occurring on the day of examination and during follow-up until capsule excretion is confirmed.

  perioperative/periprocedural

Secondary Outcomes (2)

• Complications associated with each examination method

  perioperative/periprocedural

• Patient acceptability and tolerability of each examination method

  perioperative/periprocedural

Study Arms (1)

adult individuals with genetically confirmed Lynch syndrome scheduled to surveillance-colonoscopy

Procedure: colon capsule endoscopy

Interventions

colon capsule endoscopy PROCEDURE

colon capsule endoscopy

adult individuals with genetically confirmed Lynch syndrome scheduled to surveillance-colonoscopy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults aged 18-60 years with genetically confirmed Lynch syndrome who are referred for guideline-based surveillance colonoscopy at Skåne University Hospital, Malmö. Eligible participants are identified by referring physicians at the endoscopy unit or gastroenterology outpatient clinic. Consecutive patients who meet the inclusion criteria and have no contraindications to colon capsule endoscopy or study participation are invited to enroll. Participants undergo both non-invasive colon capsule endoscopy and conventional colonoscopy according to the study protocol. Written informed consent is obtained by a study physician prior to any study-related procedures and documented in the medical record. Participation is voluntary, and participants may withdraw at any time without impact on future medical care. A total of 80 consecutive patients will be enrolled. The study evaluates the diagnostic performance and safety of colon capsule endoscopy as a first-line

You may qualify if:

• Genetically confirmed Lynch syndrome with a planned surveillance colonoscopy according to guideline-based recommendations
• Age 18-60 years
• Written informed consent obtained

You may not qualify if:

• Need for an translator
• Known history of gastroparesis or intestinal pseudo-obstruction
• Known or suspected stricture or stenosis of the gastrointestinal tract
• Previous small bowel or colonic resection
• Dysphagia or swallowing difficulties
• Severe debilitating disease
• Allergy or contraindication to any medications or products used in the study
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skane University Hospital Malmö

Malmö, Skåne County, 20502, Sweden

Location

Related Publications (12)

• American Gastroenterological Association. Lynch Syndrome: AGA Patient Guideline Summary. Gastroenterology. 2015 Sep;149(3):814-5. doi: 10.1053/j.gastro.2015.07.020. Epub 2015 Jul 26. No abstract available.

  PMID: 26219483 BACKGROUND

• Sanchez A, Roos VH, Navarro M, Pineda M, Caballol B, Moreno L, Carballal S, Rodriguez-Alonso L, Ramon Y Cajal T, Llort G, Pinol V, Lopez-Fernandez A, Salces I, Pico MD, Rivas L, Bujanda L, Garzon M, Pizarro A, Martinez de Castro E, Lopez-Arias MJ, Poves C, Garau C, Rodriguez-Alcalde D, Herraiz M, Alvarez-Urrutia C, Dacal A, Carrillo-Palau M, Cid L, Ponce M, Barreiro-Alonso E, Saperas E, Aguirre E, Romero C, Bastiaansen B, Gonzalez-Acosta M, Morales-Romero B, Ocana T, Rivero-Sanchez L, Jung G, Bessa X, Cubiella J, Jover R, Rodriguez-Moranta F, Balmana J, Brunet J, Castells A, Dekker E, Capella G, Serra-Burriel M, Moreira L, Pellise M, Balaguer F. Quality of Colonoscopy Is Associated With Adenoma Detection and Postcolonoscopy Colorectal Cancer Prevention in Lynch Syndrome. Clin Gastroenterol Hepatol. 2022 Mar;20(3):611-621.e9. doi: 10.1016/j.cgh.2020.11.002. Epub 2020 Nov 3.

  PMID: 33157315 BACKGROUND

• Lindberg LJ, Rasmussen M, Andersen KK, Nilbert M, Therkildsen C. Benefit from extended surveillance interval on colorectal cancer risk in Lynch syndrome. Colorectal Dis. 2020 May;22(5):529-536. doi: 10.1111/codi.14926. Epub 2020 Feb 3.

  PMID: 31860758 BACKGROUND

• Komanduri S, Dominitz JA, Rabeneck L, Kahi C, Ladabaum U, Imperiale TF, Byrne MF, Lee JK, Lieberman D, Wang AY, Sultan S, Shaukat A, Pohl H, Muthusamy VR. AGA White Paper: Challenges and Gaps in Innovation for the Performance of Colonoscopy for Screening and Surveillance of Colorectal Cancer. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2198-2209.e3. doi: 10.1016/j.cgh.2022.03.051. Epub 2022 Jun 7.

  PMID: 35688352 BACKGROUND

• Bie AKL, Brodersen J. Why do some participants in colorectal cancer screening choose not to undergo colonoscopy following a positive test result? A qualitative study. Scand J Prim Health Care. 2018 Sep;36(3):262-271. doi: 10.1080/02813432.2018.1487520.

  PMID: 30238859 BACKGROUND

• Kobaek-Larsen M, Kroijer R, Dyrvig AK, Buijs MM, Steele RJC, Qvist N, Baatrup G. Back-to-back colon capsule endoscopy and optical colonoscopy in colorectal cancer screening individuals. Colorectal Dis. 2018 Jun;20(6):479-485. doi: 10.1111/codi.13965.

  PMID: 29166546 BACKGROUND

• Thygesen MK, Baatrup G, Petersen C, Qvist N, Kroijer R, Kobaek-Larsen M. Screening individuals' experiences of colonoscopy and colon capsule endoscopy; a mixed methods study. Acta Oncol. 2019;58(sup1):S71-S76. doi: 10.1080/0284186X.2019.1581372. Epub 2019 Mar 1.

  PMID: 30821625 BACKGROUND

• Cortegoso Valdivia P, Skonieczna-Zydecka K, Elosua A, Sciberras M, Piccirelli S, Rullan M, Tabone T, Gawel K, Stachowski A, Leminski A, Marlicz W, Fernandez-Urien I, Ellul P, Spada C, Pennazio M, Toth E, Koulaouzidis A. Indications, Detection, Completion and Retention Rates of Capsule Endoscopy in Two Decades of Use: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2022 Apr 28;12(5):1105. doi: 10.3390/diagnostics12051105.

  PMID: 35626261 BACKGROUND

• Kroijer R, Kobaek-Larsen M, Qvist N, Knudsen T, Baatrup G. Colon capsule endoscopy for colonic surveillance. Colorectal Dis. 2019 May;21(5):532-537. doi: 10.1111/codi.14557. Epub 2019 Feb 5.

  PMID: 30637886 BACKGROUND

• Williams MH, Hadjinicolaou AV, Norton BC, Kader R, Lovat LB. Lynch syndrome: from detection to treatment. Front Oncol. 2023 May 1;13:1166238. doi: 10.3389/fonc.2023.1166238. eCollection 2023.

  PMID: 37197422 BACKGROUND

• Rosvall A, Axelsson M, Toth E, Kumlien C, Gershater MA. Development and content validity testing of a colonoscopy-specific patient-reported experience measure: the Patient Experience Colonoscopy Scale (PECS). J Patient Rep Outcomes. 2024 Mar 18;8(1):32. doi: 10.1186/s41687-024-00710-2.

  PMID: 38498225 BACKGROUND

• Perrod G, Samaha E, Perez-Cuadrado-Robles E, Berger A, Benosman H, Khater S, Vienne A, Cuenod CA, Zaanan A, Laurent-Puig P, Rahmi G, Cellier C. Effectiveness of a dedicated small bowel neoplasia screening program by capsule endoscopy in Lynch syndrome: 5 years results from a tertiary care center. Ther Adv Gastroenterol. 2020 Jul 29;13:1756284820934314. doi: 10.1177/1756284820934314. eCollection 2020.

  PMID: 32774463 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Gabriele Wurm Johansson, Docent

CONTACT

+46 40 338662; gabriele.wurmjohansson@skane.se

Ervin Toth, Docent

CONTACT

+46 70 8686286; ervin.toth@med.lu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: March 3, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)