Diagnostic Usefulness of Different Types of Gastrointestinal Endoscopic Investigations.

Colo-rectal Cancer Clinical Trial

Official title:

Diagnostic Usefulness of Different Types of Gastrointestinal Endoscopic Investigations.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04585516
• Other study ID #: 274964
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: January 2028

Study information

• Verified date: October 2020
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Patients <18 years

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Intervention

Procedure:
• endoscopy
Colonoscopy or gastroscopy

Locations

Country	Name	City	State
Sweden	University hospital	Örebro	Egion Rebro Ounty

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient characteristics in patients who were admitted for colonoscopy 1	proportion of patients with weight loss >10%	September 2016 - December 2018
Other	Patient characteristics in patients who were admitted for colonoscopy 2	age	September 2016 - December 2018
Other	Patient characteristics in patients who were admitted for colonoscopy 3	male/female	September 2016 - December 2018 0
Other	symptom characteristics in patients who were admitted for colonoscopy 1	proportion of patients with loose stools	September 2016 - December 2018
Other	symptom characteristics in patients who were admitted for colonoscopy 2	proportion of patients with constipation	September 2016 - December 2018
Other	symptom characteristics in patients who were admitted for colonoscopy 3	proportion of patients with altered bowel function specified	September 2016 - December 2018
Other	symptom characteristics in patients who were admitted for colonoscopy 4	proportion of patients with abnormal radiology	September 2016 - December 2018
Other	symptom characteristics in patients who were admitted for colonoscopy 5	proportion of patients with abnormal rectal examination	September 2016 - December 2018
Other	symptom characteristics in patients who were admitted for colonoscopy 6	proportion of patients with rectal bleeding without obvious source	September 2016 - December 2018
Other	symptom characteristics in patients who were admitted for colonoscopy 7	proportion of patients with rectal bleeding despite adequate treatment	September 2016 - December 2018
Other	symptom characteristics in patients who were admitted for colonoscopy 8	proportion of high-risk patients with rectal bleeding	September 2016 - December 2018
Other	symptom characteristics in patients who were admitted for colonoscopy 9	proportion of patients with anemia of unknown cause	September 2016 - December 2018
Other	symptom characteristics in patients who were admitted for colonoscopy 10	proportion of patients with positive fecal occult blood test	September 2016 - December 2018
Other	symptom characteristics in patients who were admitted for colonoscopy 11	proportion of patients with increased fecal calprotectin	September 2016 - December 2018
Other	Endoscopic finding in patients who were admitted for colonoscopy 1	Proportion of patients with polyps high-grade/low grade dysplasia	September 2016 - December 2018
Other	Endoscopic finding in patients who were admitted for colonoscopy 2	Proportion of patients with diverticulosis	September 2016 - December 2018
Other	Endoscopic finding in patients who were admitted for colonoscopy 3	Proportion of patients with inflammation unspecified	September 2016 - December 2018
Other	Endoscopic finding in patients who were admitted for colonoscopy 4	Proportion of patients with IBD	September 2016 - December 2018
Other	Endoscopic finding in patients who were admitted for colonoscopy 5	Proportion of patients with infectious colitis	September 2016 - December 2018
Other	Endoscopic finding in patients who were admitted for colonoscopy 6	Proportion of patients with microscopic colitis	September 2016 - December 2018
Other	Endoscopic finding in patients who were admitted for colonoscopy 7	Proportion of patients with diverticulitis	September 2016 - December 2018
Other	Endoscopic finding in patients who were admitted for colonoscopy 8	Proportion of patients with hemorrhoids	September 2016 - December 2018
Other	Endoscopic finding in patients who were admitted for colonoscopy 9	Proportion of patients with angiodysplasia	September 2016 - December 2018
Other	Endoscopic finding in patients who were admitted for colonoscopy 10	Proportion of patients with no findings.	September 2016 - December 2018
Other	Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 1	proportion of patients with weight loss >10%	Jan 2019-April 2020
Other	Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 2	proportion of patients with loss of appetite	Jan 2019-April 2020
Other	Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 3	proportion of patients with dysphagia	Jan 2019-April 2020
Other	Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 4	proportion of patients with vomiting	Jan 2019-April 2020
Other	Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 5	proportion of patients with jaundice	Jan 2019-April 2020
Other	Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 6	proportion of patients with GERD/oesofagitis	Jan 2019-April 2020
Other	Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 7	proportion of patients with gastritis	Jan 2019-April 2020
Other	Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 8	proportion of patients with peptic ulcer disease	Jan 2019-April 2020
Other	Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 9	proportion of patients with dysplasia/cancer	Jan 2019-April 2020
Other	Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 10	proportion of patients with IBD	Jan 2019-April 2020
Other	Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 11	proportion of patients with celiac disease	Jan 2019-April 2020
Other	Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 12	proportion of patients who meet Rome IV criteria for functional dyspepsia.	Jan 2019-April 2020
Other	Symptom characteristics in patients < 50 years who were admitted for a gastroscopy 13	proportion of patients with other unspecified pathology	Jan 2019-April 2020
Other	Patients characteristics in patients < 50 years who were admitted for a gastroscopy 1	male/female	Jan 2019-April 2020
Other	Patients characteristics in patients < 50 years who were admitted for a gastroscopy 2	proportion of patients who smoke	Jan 2019-April 2020
Other	Patients characteristics in patients < 50 years who were admitted for a gastroscopy 3	proportion of patients with age 18-29, age 30-39, age 40-49.	Jan 2019-April 2020
Other	Patients characteristics in patients < 50 years who were admitted for a gastroscopy 4	proportion of patients using NSAIDs/ASA	Jan 2019-April 2020
Other	Patients characteristics in patients < 50 years who were admitted for a gastroscopy 5	proportion of patients who had done a h. pylori test	Jan 2019-April 2020
Other	Patients characteristics in patients < 50 years who were admitted for a gastroscopy 6	proportion of patients with a positive h. pylori test	Jan 2019-April 2020
Other	Patients characteristics in patients < 50 years who were admitted for a gastroscopy 7	proportion of patients who were eradicated after a positive h. pylori test	Jan 2019-April 2020
Other	Patients characteristics in patients < 50 years who were admitted for a gastroscopy 8	ethnicity of patients (proportion caucasian origin, African origin, arabic origin, asian origin)	Jan 2019-April 2020
Other	Patients characteristics in patients < 50 years who were admitted for a gastroscopy 9	days between referral and gastroscopy	Jan 2019-April 2020
Primary	All confirmed colorectal cancer cases that were diagnosed via colonoscopy.	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.	between September 2016 and December 2018
Primary	Proportion of patients that was diagnosed with colorectal cancer. with colorectal cancer	All patients that were admitted to the endoscopy unit according to the standardized course of care for colorectal cancer.	between September 2016 and December 2018
Primary	Presence of upper GI pathology	The proportion of upper GI pathology in all patients <50 years who were admitted for a gastroscopy	between Jan 2019-April 2020
Secondary	route of colorectal cancer diagnosis 1	The proportion of patients with confirmed colorectal cancer that was diagnosed with colonoscopy according to the standardized chain of care for colorectal cancer.	January 2016 and December 2018
Secondary	route of colorectal cancer diagnosis 2	The proportion of patients with confirmed colorectal cancer that was diagnosed with routine colonoscopy.	January 2016 and December 2018
Secondary	Localization of colorectal cancer	The site of the tumor in confirmed colorectal cancer	January 2016 and December 2018
Secondary	tumor characteristics of colorectal cancer 1	The stage of the tumor in confirmed colorectal cancer	January 2016 and December 2018
Secondary	tumor characteristics of colorectal cancer 2	The histology of the tumor in confirmed colorectal cancer	January 2016 and December 2018
Secondary	symptom characteristics of colorectal cancer 1	proportion of patients with changes in bowel habits >4 weeks in patients with confirmed colorectal cancer	January 2016 and December 2018
Secondary	symptom characteristics of colorectal cancer 2	proportion of patients with radiology in patients with confirmed colorectal cancer	January 2016 and December 2018
Secondary	symptom characteristics of colorectal cancer 3	proportion of patients with abnormal rectal finding via palpation or rectoscopy in patients with confirmed colorectal cancer	January 2016 and December 2018
Secondary	symptom characteristics of colorectal cancer 4	proportion of patients with rectal bleeding without obvious source in patients with confirmed colorectal cancer	January 2016 and December 2018
Secondary	symptom characteristics of colorectal cancer 5	proportion of patients with rectal bleeding despite adequate treatment of bleeding source in patients with confirmed colorectal cancer	January 2016 and December 2018
Secondary	symptom characteristics of colorectal cancer 6	proportion of patients with rectal bleeding in high-risk patients with confirmed colorectal cancer	January 2016 and December 2018
Secondary	symptom characteristics of colorectal cancer 7	proportion of patients with bleeding anemia of unknown source in patients with confirmed colorectal cancer	January 2016 and December 2018
Secondary	patient characteristics of colorectal cancer 1	male/female	January 2016 and December 2018
Secondary	patient characteristics of colorectal cancer 2	age	January 2016 and December 2018
Secondary	patient characteristics of colorectal cancer 3	hemoglobine value	January 2016 and December 2018
Secondary	patient characteristics of colorectal cancer 4	calprotectin value	January 2016 and December 2018
Secondary	patient characteristics of colorectal cancer 5	Days between referral and colonoscopy	January 2016 and December 2018
Secondary	patient characteristics of colorectal cancer 6	referral from primary health care yes/no	January 2016 and December 2018
Secondary	patient characteristics of colorectal cancer 7	referral year: 2017/2017/2018	January 2016 - December 2018