Diagnostic Usefulness of Different Types of Gastrointestinal Endoscopic Investigations.

• ClinicalTrials.gov Identifier: NCT04585516
• Recruitment Status: Active, not recruiting
• First Posted: October 14, 2020
• Last Update Posted: October 14, 2020
• Sponsor: Region Örebro County
• Information provided by (Responsible Party): Michiel van Nieuwenhoven, Region Örebro County

Study Description

Brief Summary:

The number of endoscopies performed varies greatly between different countries and does not reflect variations in disease incidents. The costs of unnecessary endoscopies are significant and with a better selection of which patients need to be examined with endoscopy, resources could be saved in healthcare, and a better triage would mean that malignancies and other more serious conditions do not have to wait. An example of unnecessary endoscopy is a colonoscopy in patients with irritable bowel syndrome or gastroscopy in patients with functional dyspepsia.

The purpose of the project is, among other things:

• What diagnostic benefit have gastroscopy, colonoscopy, capsule endoscopy and double balloon enteroscopy for different indications in different age groups?
• What are the risks of this type of examination?
• Can patients be better selected based on symptoms, psychometric data or laboratory findings to reduce the number of unnecessary examinations and prioritize those that should be scooped up first?
• Can changed calling methods reduce the number of late cancellations and rebookings and missed patients?

Condition or disease	Intervention/treatment
Colo-rectal Cancer; Gastrointestinal Disease	Procedure: endoscopy

Detailed Description:

1: Identification of colorectal cancer in Örebro Region - Effectiveness of Standardised Course of Care.

Introduction: To shorten time to diagnosis of suspected colorectal cancer (CRC) in Sweden, CRC was included in the "standardised course of care" (SCC) in 2016. However, not all patients with CRC are referred via the SCC, and CRC is also found in patients undergoing a routine colonoscopy.

Objective: To identify CRC cases in the Örebro Region and how they were identified. Furthermore, to investigate the reasons for and possible effect of not being included in the SCC-CRC for cases found via colonoscopy.

Methods: Reviewing medical records of patients with CRC referred to the Clinic of Surgery in the Örebro Region in 2016-2018 (n=459).

The information recalled from the journals includes diagnostic pathway of CRC discovery, age, gender, Body Mass Index (BMI), Hb-value, date of referral to colonoscopy, date of preformed colonoscopy, referral route (SCC-CRC or non-CRC-SCC), reasons for referral (including SCC-CRC criteria) and patient symptoms. Furthermore, we will gather data of tumor localization (caecum; ascending colon; splenic flexure; transverse colon; hepatic flexure; descending colon; sigmoid and rectum), TNM-stage of the tumor, [11] tumor differentiation (high grade or low grade tumor), and source of referral (referral by general practitioner or referral by hospital physician).

Age is determined at the time of referral. BMI is defined as the most recent BMI value at time of referral within six months prior or six months after referral date. Hb-value will be defined as the most recent Hb-value within a month prior of the time of referral. Diagnostic interval is defined as the number of days days between the referral and the colonoscopy. When the tumor localization is described as in between two locations of the colon (e.g. descendent colon and sigmoid colon) the most proximal location is chosen for statistical analysis. Patients with two or more synchronous cancers are registered as more than one incident per case. When the tumor localization is described as being present in the rectosigmoid transition, the sigmoid is used as the tumor localization in the analysis. When patients have two or more symptoms and reasons for referral, data are registered as more than one incident per case. TNM stage is converted to tumor stage I-IV. [1] When patients have one or more synchronic cancer with different TNM stages, the highest cancer stage is chosen for analysis. If the TNM stage is not fully known (e.g. information about lymph nodes and metastases are missing) the stage is set as no lymph node engagement or metastases, If the original referral cannot be found, date and reasons for referral are collected from journal entries.

2: The Swedish standardized course of care for colorectal cancer - cancer prevalence and predictive values of entry criteria.

Introduction: To shorten waiting times for cancer treatment and to reduce national inequalities in cancer care, the standardized course of care (SCC) was implemented in Sweden. The SCC for colorectal cancer (CRC-SCC) was implemented in 2016. Since then, about 46.000 patients have been examined according to a CRC-SCC. However, few studies have been conducted to evaluate the CRC-SCC.

Aim: To identify the prevalence of colorectal cancer (CRC) in patients referred to Örebro University Hospital (USÖ) according to a CRC-SCC. We also aimed to investigate the positive predicting values (PPVs) and odds ratios (ORs) of different SCC-criteria with respect to CRC.

Method: Medical record review including all patients examined by colonoscopy as part of a CRC-SCC-referral to USÖ between September, 2016 and December 2018 (n=1271).The parameters of interest include; patient characteristics such as sex and age, the SCC-criteria for reasonable suspicion of cancer. If the patient has an altered bowel function it is registered whether the patient has loose stool, constipation, a combination of the two, or not specified in the referral. Rectal bleeding is defined as fresh rectal bleeding, excluding melaena. Patients who fulfill multiple criteria are registered as more than one incidence case. Laboratory values such as fecal occult blood, plasma-hemoglobin, and fecal-calprotectin (F-calprotectin) are registered. The most resent value at the time of referral is used. If there is no value within a month of the referral, no value was registered. A patient is regarded to have a positive fecal occult blood test (FOBT) if at least one out of three tests is positive. A f-calprotectin <50mg/kg is considered negative. Findings from the colonoscopy such as CRC, polyps, inflammation of the colon, diverticulosis, hemorrhoids, angiodysplasia or no finding are registered. All findings with colonoscopy are, if possible, histologically verified.

3: Why do we perform gastroscopy in younger patients?

Background: Esophagogastroduodenoscopy (EGD) is the golden standard diagnostic method in upper GI pathologies. The current guidelines indicate that patients with alarm symptoms and/or dyspeptic patients over 50 years of age should be readily investigated with gastroscopy. However, EGD is also frequently performed in the younger population, where it often results in absence of pathological findings. In Örebro approximately 4000 EGD are completed yearly, approximately 40% of the EGD's are performed in patients >50 years, requiring extensive resources.

Aim: to identify factors in the EGD referrals of patients under 50 years of age without alarm symptoms, in order to minimize the number of unnecessary EGD's in this age group.

Method and material: The study will be conducted as a retrospective database study. We will process the EGD referrals and diagnostic findings of young patients (age 18-50 y) performed during 2017-2019 at Örebro University Hospital. Statistical analysis will be performed to identify which signs and symptoms are associated with a pathological finding during EGD and which signs and symptoms are associated with a negative finding. The parameters of interest include; patient characteristics such as sex and age will separately analyze the groups 18-29y, 30-39y, and 40-49 y. Other parameters include: BMI, ethnicity, use of NSAID/ASA, h. pylori analysis, eventual treatment for h. pylori, smoking, alcohol consumption,presence of GI disease before gastroscopy, previously done gastroscopy, source of referral (primary health care or in-hospital patients), if present: fulfillment of Rome IV criteria for functional dyspepsia, symptoms such as anemia, fecal occult blood, palpable mass in abdomen, weight loss, loss of appetite, dysphagia, vomiting, jaundice, waiting time between referral and gastroscopy, as well as the findings under gastroscopy; GERD/oesofagitis, peptic ulcus, gastritis, dysplasia/cancer, IBD, celiac disease, hiatal hernia

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Other
• Target Follow-Up Duration: 1 Year
• Official Title: Diagnostic Usefulness of Different Types of Gastrointestinal Endoscopic Investigations.
• Actual Study Start Date: January 1, 2020
• Estimated Primary Completion Date: January 2028
• Estimated Study Completion Date: January 2028

Groups and Cohorts

Group/Cohort	Intervention/treatment
Patient with suspected colorectal cancer; All patients that were admitted to the department of surgery with suspected colorectal cancer between January 2016 and December 2018 (n=459).	Procedure: endoscopy; Colonoscopy or gastroscopy
Patients admitted according to the standardized course of care for colorectal cancer; All patients that were admitted to the endoscopy department according to the standardized course of care for colorectal cancer between September 2016 and December 2018 (n=1271).	Procedure: endoscopy; Colonoscopy or gastroscopy
Patients < 50 years that were admitted for gastroscopy; All patients younger than 50 years that were admitted to the endoscopy department for a gastroscopy between jan 2018 and April 2019 (n= 1915)	Procedure: endoscopy; Colonoscopy or gastroscopy
Patients >80 years that were admitted for colonoscopy; All patients older than 80 years that were admitted to the endoscopy department for a colonoscopy between Sept 2016 and Jan 2019 (n= 981)	Procedure: endoscopy; Colonoscopy or gastroscopy

Outcome Measures

Primary Outcome Measures :

1. All confirmed colorectal cancer cases that were diagnosed via colonoscopy. [ Time Frame: between September 2016 and December 2018 ]
   The proportion of patients that was admitted to the department of surgery with confirmed colorectal cancer, diagnosed according to the standardized course of care for colorectal cancer.
2. Proportion of patients that was diagnosed with colorectal cancer. with colorectal cancer [ Time Frame: between September 2016 and December 2018 ]
   All patients that were admitted to the endoscopy unit according to the standardized course of care for colorectal cancer.
3. Presence of upper GI pathology [ Time Frame: between Jan 2019-April 2020 ]
   The proportion of upper GI pathology in all patients <50 years who were admitted for a gastroscopy

Secondary Outcome Measures :

1. route of colorectal cancer diagnosis 1 [ Time Frame: January 2016 and December 2018 ]
   The proportion of patients with confirmed colorectal cancer that was diagnosed with colonoscopy according to the standardized chain of care for colorectal cancer.
2. route of colorectal cancer diagnosis 2 [ Time Frame: January 2016 and December 2018 ]
   The proportion of patients with confirmed colorectal cancer that was diagnosed with routine colonoscopy.
3. Localization of colorectal cancer [ Time Frame: January 2016 and December 2018 ]
   The site of the tumor in confirmed colorectal cancer
4. tumor characteristics of colorectal cancer 1 [ Time Frame: January 2016 and December 2018 ]
   The stage of the tumor in confirmed colorectal cancer
5. tumor characteristics of colorectal cancer 2 [ Time Frame: January 2016 and December 2018 ]
   The histology of the tumor in confirmed colorectal cancer
6. symptom characteristics of colorectal cancer 1 [ Time Frame: January 2016 and December 2018 ]
   proportion of patients with changes in bowel habits >4 weeks in patients with confirmed colorectal cancer
7. symptom characteristics of colorectal cancer 2 [ Time Frame: January 2016 and December 2018 ]
   proportion of patients with radiology in patients with confirmed colorectal cancer
8. symptom characteristics of colorectal cancer 3 [ Time Frame: January 2016 and December 2018 ]
   proportion of patients with abnormal rectal finding via palpation or rectoscopy in patients with confirmed colorectal cancer
9. symptom characteristics of colorectal cancer 4 [ Time Frame: January 2016 and December 2018 ]
   proportion of patients with rectal bleeding without obvious source in patients with confirmed colorectal cancer
10. symptom characteristics of colorectal cancer 5 [ Time Frame: January 2016 and December 2018 ]
    proportion of patients with rectal bleeding despite adequate treatment of bleeding source in patients with confirmed colorectal cancer
11. symptom characteristics of colorectal cancer 6 [ Time Frame: January 2016 and December 2018 ]
    proportion of patients with rectal bleeding in high-risk patients with confirmed colorectal cancer
12. symptom characteristics of colorectal cancer 7 [ Time Frame: January 2016 and December 2018 ]
    proportion of patients with bleeding anemia of unknown source in patients with confirmed colorectal cancer
13. patient characteristics of colorectal cancer 1 [ Time Frame: January 2016 and December 2018 ]
    male/female
14. patient characteristics of colorectal cancer 2 [ Time Frame: January 2016 and December 2018 ]
    age
15. patient characteristics of colorectal cancer 3 [ Time Frame: January 2016 and December 2018 ]
    hemoglobine value
16. patient characteristics of colorectal cancer 4 [ Time Frame: January 2016 and December 2018 ]
    calprotectin value
17. patient characteristics of colorectal cancer 5 [ Time Frame: January 2016 and December 2018 ]
    Days between referral and colonoscopy
18. patient characteristics of colorectal cancer 6 [ Time Frame: January 2016 and December 2018 ]
    referral from primary health care yes/no
19. patient characteristics of colorectal cancer 7 [ Time Frame: January 2016 - December 2018 ]
    referral year: 2017/2017/2018

Other Outcome Measures:

1. Patient characteristics in patients who were admitted for colonoscopy 1 [ Time Frame: September 2016 - December 2018 ]
   proportion of patients with weight loss >10%
2. Patient characteristics in patients who were admitted for colonoscopy 2 [ Time Frame: September 2016 - December 2018 ]
   age
3. Patient characteristics in patients who were admitted for colonoscopy 3 [ Time Frame: September 2016 - December 2018 0 ]
   male/female
4. symptom characteristics in patients who were admitted for colonoscopy 1 [ Time Frame: September 2016 - December 2018 ]
   proportion of patients with loose stools
5. symptom characteristics in patients who were admitted for colonoscopy 2 [ Time Frame: September 2016 - December 2018 ]
   proportion of patients with constipation
6. symptom characteristics in patients who were admitted for colonoscopy 3 [ Time Frame: September 2016 - December 2018 ]
   proportion of patients with altered bowel function specified
7. symptom characteristics in patients who were admitted for colonoscopy 4 [ Time Frame: September 2016 - December 2018 ]
   proportion of patients with abnormal radiology
8. symptom characteristics in patients who were admitted for colonoscopy 5 [ Time Frame: September 2016 - December 2018 ]
   proportion of patients with abnormal rectal examination
9. symptom characteristics in patients who were admitted for colonoscopy 6 [ Time Frame: September 2016 - December 2018 ]
   proportion of patients with rectal bleeding without obvious source
10. symptom characteristics in patients who were admitted for colonoscopy 7 [ Time Frame: September 2016 - December 2018 ]
    proportion of patients with rectal bleeding despite adequate treatment
11. symptom characteristics in patients who were admitted for colonoscopy 8 [ Time Frame: September 2016 - December 2018 ]
    proportion of high-risk patients with rectal bleeding
12. symptom characteristics in patients who were admitted for colonoscopy 9 [ Time Frame: September 2016 - December 2018 ]
    proportion of patients with anemia of unknown cause
13. symptom characteristics in patients who were admitted for colonoscopy 10 [ Time Frame: September 2016 - December 2018 ]
    proportion of patients with positive fecal occult blood test
14. symptom characteristics in patients who were admitted for colonoscopy 11 [ Time Frame: September 2016 - December 2018 ]
    proportion of patients with increased fecal calprotectin
15. Endoscopic finding in patients who were admitted for colonoscopy 1 [ Time Frame: September 2016 - December 2018 ]
    Proportion of patients with polyps high-grade/low grade dysplasia
16. Endoscopic finding in patients who were admitted for colonoscopy 2 [ Time Frame: September 2016 - December 2018 ]
    Proportion of patients with diverticulosis
17. Endoscopic finding in patients who were admitted for colonoscopy 3 [ Time Frame: September 2016 - December 2018 ]
    Proportion of patients with inflammation unspecified
18. Endoscopic finding in patients who were admitted for colonoscopy 4 [ Time Frame: September 2016 - December 2018 ]
    Proportion of patients with IBD
19. Endoscopic finding in patients who were admitted for colonoscopy 5 [ Time Frame: September 2016 - December 2018 ]
    Proportion of patients with infectious colitis
20. Endoscopic finding in patients who were admitted for colonoscopy 6 [ Time Frame: September 2016 - December 2018 ]
    Proportion of patients with microscopic colitis
21. Endoscopic finding in patients who were admitted for colonoscopy 7 [ Time Frame: September 2016 - December 2018 ]
    Proportion of patients with diverticulitis
22. Endoscopic finding in patients who were admitted for colonoscopy 8 [ Time Frame: September 2016 - December 2018 ]
    Proportion of patients with hemorrhoids
23. Endoscopic finding in patients who were admitted for colonoscopy 9 [ Time Frame: September 2016 - December 2018 ]
    Proportion of patients with angiodysplasia
24. Endoscopic finding in patients who were admitted for colonoscopy 10 [ Time Frame: September 2016 - December 2018 ]
    Proportion of patients with no findings.
25. Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 1 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with weight loss >10%
26. Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 2 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with loss of appetite
27. Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 3 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with dysphagia
28. Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 4 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with vomiting
29. Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 5 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with jaundice
30. Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 6 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with GERD/oesofagitis
31. Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 7 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with gastritis
32. Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 8 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with peptic ulcer disease
33. Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 9 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with dysplasia/cancer
34. Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 10 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with IBD
35. Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 11 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with celiac disease
36. Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 12 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients who meet Rome IV criteria for functional dyspepsia.
37. Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 13 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with other unspecified pathology
38. Patients characteristics in patients < 50 years who were admitted for a gastroscopy 1 [ Time Frame: Jan 2019-April 2020 ]
    male/female
39. Patients characteristics in patients < 50 years who were admitted for a gastroscopy 2 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients who smoke
40. Patients characteristics in patients < 50 years who were admitted for a gastroscopy 3 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with age 18-29, age 30-39, age 40-49.
41. Patients characteristics in patients < 50 years who were admitted for a gastroscopy 4 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients using NSAIDs/ASA
42. Patients characteristics in patients < 50 years who were admitted for a gastroscopy 5 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients who had done a h. pylori test
43. Patients characteristics in patients < 50 years who were admitted for a gastroscopy 6 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients with a positive h. pylori test
44. Patients characteristics in patients < 50 years who were admitted for a gastroscopy 7 [ Time Frame: Jan 2019-April 2020 ]
    proportion of patients who were eradicated after a positive h. pylori test
45. Patients characteristics in patients < 50 years who were admitted for a gastroscopy 8 [ Time Frame: Jan 2019-April 2020 ]
    ethnicity of patients (proportion caucasian origin, African origin, arabic origin, asian origin)
46. Patients characteristics in patients < 50 years who were admitted for a gastroscopy 9 [ Time Frame: Jan 2019-April 2020 ]
    days between referral and gastroscopy

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent an endoscopic diagnostic procedure.

Criteria

Inclusion Criteria:

All patients who underwent a diagnostic diagnostic procedure at the endoscopy unit at the University Hospital Örebro.

Exclusion Criteria:

Patients <18 years

Contacts and Locations

Locations

Sweden

University hospital

Örebro, Egion Rebro Ounty, Sweden, 70185

Sponsors and Collaborators

Region Örebro County

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Andersson E, Nyhlin N, van Nieuwenhoven MA. The effectiveness of the colorectal cancer referral pathway - identification of colorectal cancer in a Swedish region. Scand J Gastroenterol. 2021 May;56(5):552-558. doi: 10.1080/00365521.2021.1899276. Epub 2021 Mar 22.

• Responsible Party: Michiel van Nieuwenhoven, Md, MSc, associate professor, Region Örebro County
• ClinicalTrials.gov Identifier: NCT04585516
• Other Study ID Numbers: 274964
• First Posted: October 14, 2020
• Last Update Posted: October 14, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Michiel van Nieuwenhoven, Region Örebro County:

colonoscopy; gastroscopy

Additional relevant MeSH terms:

Gastrointestinal Diseases; Digestive System Diseases