Diagnostic Usefulness of Different Types of Gastrointestinal Endoscopic Investigations.

NCT ID: NCT04585516

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2028-01-31

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?

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

Conditions

Colo-rectal Cancer; Gastrointestinal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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).

endoscopy

Intervention Type: PROCEDURE

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).

endoscopy

Intervention Type: PROCEDURE

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)

endoscopy

Intervention Type: PROCEDURE

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)

endoscopy

Intervention Type: PROCEDURE

Colonoscopy or gastroscopy

Interventions

endoscopy

Colonoscopy or gastroscopy

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Michiel van Nieuwenhoven

Md, MSc, associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University hospital

Örebro, Egion Rebro Ounty, Sweden

Countries

Sweden

References

Nguyen L, Rasanen N, Berggren F, van Nieuwenhoven MA. Assessing age-related risks of gastrointestinal pathologies: a comparative study of gastroscopy outcomes across decades. Therap Adv Gastroenterol. 2024 Oct 28;17:17562848241290446. doi: 10.1177/17562848241290446. eCollection 2024.

Reference Type: DERIVED

PMID: 39474441 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33749502 (View on PubMed)

Other Identifiers

274964

Identifier Type: -

Identifier Source: org_study_id