Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Pain

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Quality of Life

Anterolateral vs. posterolateral thoracotomy

Video assisted thoracic surgery (VATS) vs. anterolateral thoracotomy

Anterolateral thoracotomy

Standard muscle sparing posterolateral thoracotomy

Posterolateral thoracotomy

Standard video assisted thoracic surgery, no use of rib-spreader.

VATS

Anterolateral Thoracotomy

Peter B Licht, Professor

Morten Bendixen, MD

Is thoracoscopic surgery better than traditional open surgery for lung cancer?

Video assisted thoracoscopic surgery for lung cancer (VATS) is presumed to be less traumatic than traditional open surgery for lung cancer but this has never been documented in a randomized trial. Some surgeons hesitate to use VATS because it is technically more demanding, others question if the two methods are oncologically equal. Regardless, VATS has been implemented as a routine method for lung cancer surgery several places around the world including Odense University Hospital. The investigators have launched the first randomized controlled trial in the world comparing the two surgical methods to investigate any differences in length of hospitalization, postoperative pain, life quality within the first year, and health economics.

The investigators include patients with stage I and II lung cancer, and randomize between VATS and open surgery in a design where both the patient and doctors doing general rounds in the ward are blinded until discharge because the dressing on the surgical wound is identical, regardless of the surgical method. The surgeon cannot influence clinical decisions including time to discharge, which is decided by other specialist surgeons. Pain evaluation is performed 6 times daily using the VAS-score, life quality is evaluated continuously during the first 12 months using EQ5D and EORTC QLQC-30 questionnaires, and the consumption of analgetics in both groups are monitored via the national prescription database.

Parallel to this trial a similar clinical study, which is also the first of its kind in the world, has been launched for patients with lung cancers not eligible for VATS. They are randomized between the two traditional open surgical methods (anterolateral and posterolateral thoracotomy) - this is also blinded to both patient and doctors doing rounds until discharge from hospital, and endpoint are similar in the two studies.

206 patients have been randomized in the first substudy (VATS vs. open) and 88 in the second substudy (posterolateral vs. anterolateral).

Is minimally invasive surgery for non small cell lung cancer better than traditional open surgery?

Surgical resection remains the best treatment for non small cell lung carcinoma (NSCLC),but unfortunately many patients suffer major postoperative morbidity - pain being the most frequent. It is assumed that newer minimally invasive surgical techniques (Video Assisted Thoracoscopic Surgery - VATS) reduces postoperative morbidity but there is no level 1 evidence available in the literature. This prompted us to perform the present ongoing study, which is the first of its kind in the world.

The investigators compare VATS with traditional open surgery for early stage lung cancer in a clinical randomized double blinded trial. Our aims are to evaluate differences in postoperative pain, life quality, and health economical aspects. The results of this trial could influence future surgical decisionmaking internationally on the surgical treatment for lung cancer.

Likewise, in patients with larger tumours of the lung, which are not suitable for minimally invasive surgery, different techniques are available. The most widely used techniques are the posterolateral thoracotomy and the anterolateral thoracotomy. So far no randomized controlled trail has shown which of these techniques to be superior. This has led us to also randomize between anterolateral and the posterolateral thoracotomy (muscle sparing). The same endpoints are used.

Pain following lung surgery has been a much discussed topic for a long time in the field of thoracic surgery. Depending on the reference, up to 50% of patients develop chronic pain after open lung surgery. Therefore, different surgical approaches have been developed including anterior, lateral or posterior thoracotomy with or without sparing the chest wall muscles. The intercostal nerve is also of concern because of trauma from the rib retractor which is believed to be a cause of both acute and chronic pain. Other concerns are the amount of divided tissue, extend of rib displacement by the rib retractor, type of analgesics, administration form of analgesics, and administration time of the analgesics and it is generally accepted that pain in lung cancer patients is multifactorial.

VATS was introduced in an attempt to reduce the surgical trauma with less tissue damage, avoidance of the rib retraction and the consequently intercostal nerve injury, but never the less several patients develop chronic pain after lung surgery by VATS.

Information on quality of life and health economical aspects following surgery for lung cancer are scarce. No randomized controlled trial has been published. Very little is known if lung cancer patients regain their workability and if so to what extent following surgery.

Likewise, it is not known if VATS is more costly than open procedures, as the opponents say, or if increased expenses during hospitalization are saved by earlier return to work.

End points

1. Postoperative pain evaluated using the VAS-score and the need for prescription analgetics 2, 4, 8, 12, 26 and 52 weeks after surgery.
2. Health related life quality and workability and -efficiency in the same period, using three different questionnaires: two concerning life quality (EORTC-QLQC-30 and EQ5D) and one concerning workability (WPAI).
3. Health economical aspect such as application for pension, visits to general practitioner, readmitted to hospital, number of days away from work due to postoperative morbidity, etc.

All gathered from different databases managed by "Danmarks Statistik" here among the "Landspatientregistret(LPR)", "Sygesikringsstatistikregistret" ,and "Lægemiddelstatistik-registret".

206 patients admitted to the department of cardiothoracic surgery, Odense University Hospital, for elective surgery for lung cancer will be included in each study.

Design

This research project has three sub studies: Two randomized controlled and double blinded clinical trials, and one registry study. One clinical trial randomizes patients with small peripheral lung cancer between VATS (Video Assisted Thoracoscopic Surgery) and standard open anterolateral thoracotomy. The second clinical trial randomizes between anterolateral and posterolateral open thoracotomy in patients not eligible for VATS. The registry sub study monitors patients use of analgetics during the first 12 months (lægemiddelstatestik-registret), their use of other health services, and return to work.

All patients will be operated in general anaesthesia with a double lumen tracheal tube and an epidural catheter. The epidural catheter will be removed when all chest tubes has been removed, but no later than postoperative day 4.

As a standard all patients will be given paracetamol and NSAID in standard doses, and if needed opioids (oxycontin/oxynorm) can be added.

All surgical techniques will be performed as routine operations.

Three different surgical techniques will be used.

1. The VATS approach: one camera port and three assistance ports one of which is enlarged to 5 cm. and rib retractors are never used.
2. Anterolateral thoracotomy: The incision is made from the posterior axillary fold following the linea inframammary to a point below the papilla.
3. Posterolateral thoracotomy. The incision is made from the anterior axillary fold backwards towards the inferior angle of the scapula, without dividing the dorsal latissimus muscle.

In both clinical trials postoperative pain is evaluated by a visual analog scale (VAS). Pain is measured during rest and during coughing. Measurements are done preoperatively and 6 times daily during their hospital stay. After discharge measurements are recorded after 2, 4, 8, 12, 26, and 52 weeks by mail questionnaire.

Both patients and the staff doing general rounds postoperatively will be blinded. In the operating room a dressing will be placed so that it covers the entire hemithorax whereby the incision is hidden. This is done identically regardless of surgical technique. This dressing is left in place until discharge. If changing of the dressing is needed, either the project-nurse or a nurse for another team will assist.

The surgical note is kept in a sealed envelope, which is always placed in the patients chart and can be opened in case of emergency. The chart will only include information about which lobe was resected, no details on the surgical access, but this information is added when the patient is discharged.

The surgeon who has performed the operation will be allowed to check up on their own patients, and to be consulted by the other doctors doing rounds, but they are not allowed to influence on decision-making regarding pain relief or discharge, during the postoperative period.

Timeline

This project is a combination of a ph.d-study and a residency/fellowship in cardiothoracic surgery because this allows for a longer inclusion period. The timeline is divided into three research periods and three clinical periods.

This research project has already been accepted as a ph.d.-project at the University of Southern Denmark, and approved by the local ethical board.

Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economics.

Aim is to asses the development of acute and chronic pain after lobectomy.

Three questionnaires are used. EQ5D, QLQC-30 and WPAI.

An economical evaluation will be done. Including in-hospital expences, use of sociale-security, readmissions to hospital, use of family practioner, use of and duration of prescription analgetics, wether or not patients are able to return to work, the effect this type of surgery has on the patients quality of life, including a QALY evaluation and cost utility analysis.

Peter B Licht

Professor, MD, pHd.

Skin and Connective Tissue Diseases

Immune System Diseases

Breast Neoplasms

Hypersensitivity

Breast Diseases

Skin Diseases

Synthetic Mammography (SM) + Digital Breast Tomosynthesis (DBT)

The SM+DBT will be independently read by two radiologists. A consensus meeting will decide whether to recall the woman or not.

Women selected for further assessment (positive screening exam) will be recalled.

The digital mammograms will be independently read by two radiologists. A consensus meeting will decide whether to recall the woman or not.

Two-view tomosynthesis performed with GE Senoclaire 3D Breast Tomosynthesis.

Synthetic Mammography + Digital Breast Tomosynthesis

Two-view digital mammography performed with GE Senoclaire 3D Breast Tomosynthesis.

Digital mammography

Solveig Hofvind, Professor

Compare synthetic mammography+digital breast tomosynthesis (SM+DBT) with digital mammography (DM) as a screening tool for women aged 50-69 years, invited to participate in the Norwegian Breast Cancer Screening Program at the screening unit in Bergen, Norway, with regard to early performance measures, including prognostic and predictive tumor characteristics, radiation doses and cost-effectiveness.

DBT is a new screening tool, argued to be better than standard DM. This statement is based on a lower recall rate, and a higher rate of early-stage screen-detected cancer. No studies have so far reported results from women screened with DBT from GE Healthcare, as far as the investigators know. DBT from GE offer synthetic two-dimensional DM generated from the DBT data (SM), and studies have shown similar detection rates for this technique as of adjacent DM. By comparing results of early performance measures and economic aspects in two comparable populations of women in the same age group, residing in the same county, the investigators can measure the effect of SM+DBT versus standard DM with equipment from GE Healthcare. The populations will be examined by the same radiographers, screen-read by the same radiologists, histologically breast cancer proven by the same pathologists, and treated by the same surgeons and oncologists.

A prospective cohort study targeting 45,000 women invited to breast cancer screening in Bergen, Hordaland in the study period, 2016-2018, will be performed. A screening participation of approximately 75% is expected. All attending women will be asked if they are willing to participate in the study after receiving written and oral information about the study. Women willing to participate in the study will sign an informed consent. Of the attending women it is expected that about 90-95% will consent to participate in the study. The women will be randomized into two groups, a study group and a control group. The randomization will take place at the screening unit in Bergen. The outcome of the randomization is based on the 11-digit personal identification number assigned to every citizen in Norway. In the study group, the women will be screened with SM+DBT. In the control group, the women will be screened with DM. Women not willing to participate in the study will be screened with DM, and not included in our study.

The investigators aim to address the following topics and research questions:

* Study 1: Early performance measures in a population based screening program using SM+DBT versus DM - interim analyses.
* Study 2: Use of SM+DBT versus DM in a population based screening program - a randomized controlled trial.
* Study 3: Prognostic and predictive histopathologic characteristics of breast tumors detected in a population based program using SM+DBT versus DM.
* Study 4: SM+DBT and DM in a populations based screening program - which technology has the highest sensitivity for women with mammographic dense breast?
* Study 5 and 6: Costs of SM+DBT and DM in a populations based screening program - is SM+DBT cost-effective?

The Digital Breast Tomosynthesis Trial in Bergen

Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?

We will not share the data outside the project group

The time spent on screen-reading and consensus will be compared for tomosynthesis versus digital mammography

Distribution of characteristics among the women diagnosed with breast cancer screened with tomosynthesis versus digital mammography in a population based screening program.

Radiation doses will be measured for screening with tomosynthesis and digital mammography by an automated software, in milligray (mGy).

Comparison of rates of screen-detected breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program.

Positive predictive value of recalls (number of screen-detected breast cancer among participants recalled for further assesment) for tomosynthesis versus digital mammography in a population based screening program.

Comparison of rate of recall for further assesment due to mammographic findings in tomosynthesis versus digital mammography as performed in a population based screening program.

The incremental cost per woman screened with digital breast tomosynthesis versus digital mammography in a population-based breast cancer screening program.

Rate of interval breast cancer among those screened with tomosynthesis versus digital mammography as performed in a population based screening program.

Haukeland University Hospital

University of Oslo

The Research Council of Norway

Cancer Registry of Norway

Digital Breast Tomosynthesis + Synthetic Mammography (DBT)

The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.

Women selected for further assessment (positive screening exam) was recalled.

Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis.

Digital Breast Tomosynthesis

The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.

Women selected for further assessment (positive screening exam) was recalled.

Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.

Digital Mammography

Total

<55 years

55-59 years

60-64 years

>64 years

Age, Customized

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Norway

Region of Enrollment

Prevalent (first screening)

Subsequent

Screening history

We excluded women with previous breast cancer (DBT = 314, DM = 316), women with breast symptoms at screening (DBT = 39, DM = 34) and one woman with metastasis from melanoma (DBT).

Prof. Solveig Hofvind

Number of Participants With Screen-Detected Breast Cancer

Number and Percentage of Participants Screen-Detected Breast Cancer Among Participants Recalled for Further Assesment

Number of Participants Recalled for Further Assesment Due to Mammographic Findings

Incremental costs of DBT vs. DM in Euro

Incremental cost of DBT vs. DM after adding costs of recall, in Euro

Comparing costs of procedure use and screening, recall and treatment costs estimated at the individual level for Digital Breast Tomosynthesis + Synthetic Mammography (DBT) versus Digital Mammography (DM).

Digital Breast Tomosynthesis Versus Digital Mammography

For each participant, the incremental cost of tomosynthesis vs. digital mammography were estimated, not the total cost of tomosynthesis vs. digital mammography. The investigators assumed that costs not pertaining to examination and reading times, mammograph price, IT storage and connectivity were equal for the two. This Outcome Measure was pre-specified to present the incremental costs per screened woman. By nature, incremental costs are calculated between groups.

Incremental Costs of Screening With Tomosynthesis Versus Digital Mammography

Histological type : Carcinoma (no special type)

Histological type : Lobular carcinoma

Histological type : Tubular carcinoma

Histological type : Other carcinoma

Tumor diameter : <10 mm

Tumor diameter : >=10-<20 mm

Tumor diameter : >=20 mm

Lymph node positive

Histological grade : grade 1

Histological grade : grade 2

Histological grade : grade 3

Estrogen receptor positive

Progesterone receptor positive

HER2 positive

Ki67 >=30%

When collecting information on histopathological tumor characteristics, not all participants had information available on all variables.

Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer

Number of Participants With Interval Breast Cancer

Initial screen reading

Consensus reading

Interim analysis performed on study population from the first year of the trial (2016). All cases were screen-read by two radiologist, however not all were discussed at consensus.

Time Spent on Screen-Reading and Consensus Meetings

Mammographic Features of Screen-Detected Breast Cancer

Interim analysis performed on study population from the first year of the trial (2016). Not all women had available information on radiation dose.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economics.	NCT01278888	Nonsmall Cell L...	Anterolateral t... Posterolateral ... VATS Anterolateral T...	18 Years -	Odense University Hospital
The Digital Breast Tomosynthesis Trial in Bergen	NCT02835625	Breast Neoplasm...	Synthetic Mammo... Digital mammogr...	48 Years - 71 Years	Cancer Registry of Norway
The Digital Breast Tomosynthesis Trial in Bergen	NCT02835625	Breast Neoplasm...	Synthetic Mammo... Digital mammogr...	48 Years - 71 Years	Cancer Registry of Norway

Spots Global Cancer Trial Database for economy

Every month we try and update this database with for economy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for economy

Every month we try and update this database with for economy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for economy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.