Clinical trial NCT04585516: Diagnostic Usefulness of Different Types of Gastrointestinal Endoscopic Investigations.
Official title: Diagnostic Usefulness of Different Types of Gastrointestinal Endoscopic Investigations.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colo-rectal Cancer
Gastrointestinal Disease
Keywords: colonoscopy
gastroscopy
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent an endoscopic diagnostic procedure.

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

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

Primary outcomes:
measure: All confirmed colorectal cancer cases that were diagnosed via colonoscopy.
timeFrame: between September 2016 and December 2018
measure: Proportion of patients that was diagnosed with colorectal cancer. with colorectal cancer
timeFrame: between September 2016 and December 2018
measure: Presence of upper GI pathology
timeFrame: between Jan 2019-April 2020
Secondary outcomes:
measure: route of colorectal cancer diagnosis 1
timeFrame: January 2016 and December 2018
measure: route of colorectal cancer diagnosis 2
timeFrame: January 2016 and December 2018
measure: Localization of colorectal cancer
timeFrame: January 2016 and December 2018
measure: tumor characteristics of colorectal cancer 1
timeFrame: January 2016 and December 2018
measure: tumor characteristics of colorectal cancer 2
timeFrame: January 2016 and December 2018
measure: symptom characteristics of colorectal cancer 1
timeFrame: January 2016 and December 2018
measure: symptom characteristics of colorectal cancer 2
timeFrame: January 2016 and December 2018
measure: symptom characteristics of colorectal cancer 3
timeFrame: January 2016 and December 2018
measure: symptom characteristics of colorectal cancer 4
timeFrame: January 2016 and December 2018
measure: symptom characteristics of colorectal cancer 5
timeFrame: January 2016 and December 2018
measure: symptom characteristics of colorectal cancer 6
timeFrame: January 2016 and December 2018
measure: symptom characteristics of colorectal cancer 7
timeFrame: January 2016 and December 2018
measure: patient characteristics of colorectal cancer 1
timeFrame: January 2016 and December 2018
measure: patient characteristics of colorectal cancer 2
timeFrame: January 2016 and December 2018
measure: patient characteristics of colorectal cancer 3
timeFrame: January 2016 and December 2018
measure: patient characteristics of colorectal cancer 4
timeFrame: January 2016 and December 2018
measure: patient characteristics of colorectal cancer 5
timeFrame: January 2016 and December 2018
measure: patient characteristics of colorectal cancer 6
timeFrame: January 2016 and December 2018
measure: patient characteristics of colorectal cancer 7
timeFrame: January 2016 - December 2018
Other outcomes:
measure: Patient characteristics in patients who were admitted for colonoscopy 1
timeFrame: September 2016 - December 2018
measure: Patient characteristics in patients who were admitted for colonoscopy 2
timeFrame: September 2016 - December 2018
measure: Patient characteristics in patients who were admitted for colonoscopy 3
timeFrame: September 2016 - December 2018 0
measure: symptom characteristics in patients who were admitted for colonoscopy 1
timeFrame: September 2016 - December 2018
measure: symptom characteristics in patients who were admitted for colonoscopy 2
timeFrame: September 2016 - December 2018
measure: symptom characteristics in patients who were admitted for colonoscopy 3
timeFrame: September 2016 - December 2018
measure: symptom characteristics in patients who were admitted for colonoscopy 4
timeFrame: September 2016 - December 2018
measure: symptom characteristics in patients who were admitted for colonoscopy 5
timeFrame: September 2016 - December 2018
measure: symptom characteristics in patients who were admitted for colonoscopy 6
timeFrame: September 2016 - December 2018
measure: symptom characteristics in patients who were admitted for colonoscopy 7
timeFrame: September 2016 - December 2018
measure: symptom characteristics in patients who were admitted for colonoscopy 8
timeFrame: September 2016 - December 2018
measure: symptom characteristics in patients who were admitted for colonoscopy 9
timeFrame: September 2016 - December 2018
measure: symptom characteristics in patients who were admitted for colonoscopy 10
timeFrame: September 2016 - December 2018
measure: symptom characteristics in patients who were admitted for colonoscopy 11
timeFrame: September 2016 - December 2018
measure: Endoscopic finding in patients who were admitted for colonoscopy 1
timeFrame: September 2016 - December 2018
measure: Endoscopic finding in patients who were admitted for colonoscopy 2
timeFrame: September 2016 - December 2018
measure: Endoscopic finding in patients who were admitted for colonoscopy 3
timeFrame: September 2016 - December 2018
measure: Endoscopic finding in patients who were admitted for colonoscopy 4
timeFrame: September 2016 - December 2018
measure: Endoscopic finding in patients who were admitted for colonoscopy 5
timeFrame: September 2016 - December 2018
measure: Endoscopic finding in patients who were admitted for colonoscopy 6
timeFrame: September 2016 - December 2018
measure: Endoscopic finding in patients who were admitted for colonoscopy 7
timeFrame: September 2016 - December 2018
measure: Endoscopic finding in patients who were admitted for colonoscopy 8
timeFrame: September 2016 - December 2018
measure: Endoscopic finding in patients who were admitted for colonoscopy 9
timeFrame: September 2016 - December 2018
measure: Endoscopic finding in patients who were admitted for colonoscopy 10
timeFrame: September 2016 - December 2018
measure: Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 1
timeFrame: Jan 2019-April 2020
measure: Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 2
timeFrame: Jan 2019-April 2020
measure: Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 3
timeFrame: Jan 2019-April 2020
measure: Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 4
timeFrame: Jan 2019-April 2020
measure: Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 5
timeFrame: Jan 2019-April 2020
measure: Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 6
timeFrame: Jan 2019-April 2020
measure: Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 7
timeFrame: Jan 2019-April 2020
measure: Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 8
timeFrame: Jan 2019-April 2020
measure: Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 9
timeFrame: Jan 2019-April 2020
measure: Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 10
timeFrame: Jan 2019-April 2020
measure: Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 11
timeFrame: Jan 2019-April 2020
measure: Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 12
timeFrame: Jan 2019-April 2020
measure: Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 13
timeFrame: Jan 2019-April 2020
measure: Patients characteristics in patients < 50 years who were admitted for a gastroscopy 1
timeFrame: Jan 2019-April 2020
measure: Patients characteristics in patients < 50 years who were admitted for a gastroscopy 2
timeFrame: Jan 2019-April 2020
measure: Patients characteristics in patients < 50 years who were admitted for a gastroscopy 3
timeFrame: Jan 2019-April 2020
measure: Patients characteristics in patients < 50 years who were admitted for a gastroscopy 4
timeFrame: Jan 2019-April 2020
measure: Patients characteristics in patients < 50 years who were admitted for a gastroscopy 5
timeFrame: Jan 2019-April 2020
measure: Patients characteristics in patients < 50 years who were admitted for a gastroscopy 6
timeFrame: Jan 2019-April 2020
measure: Patients characteristics in patients < 50 years who were admitted for a gastroscopy 7
timeFrame: Jan 2019-April 2020
measure: Patients characteristics in patients < 50 years who were admitted for a gastroscopy 8
timeFrame: Jan 2019-April 2020
measure: Patients characteristics in patients < 50 years who were admitted for a gastroscopy 9
timeFrame: Jan 2019-April 2020
Locations:
city: Örebro
country: Sweden
facility: University hospital
state: Egion Rebro Ounty
Study officials:
References:
citation: 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.