An observational study in Cancer, Hepatic, Cancer, Esophagus and Cancer, Pancreas, sponsored by Rigshospitalet, Denmark. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Rigshospitalet, Denmark · Observational
This study includes participants undergoing major hepatic surgery, surgery in the esophagus or stomach, or major surgery on the pancreas performed at Copenhagen University Hospital, Rigshospitalet. The aims of the study 1: To record patients' level of catastrophizing preoperatively and pain perioperatively, and pain treatment, as well as related side effects. Furthermore, to investigate whether it is possible to assign the task of rating pain scores to the patient.
2. To investigate patients' expectations preoperatively and the fulfillment of these expectations 30 days after, and the development of chronic pain after 6 months. 3. To record patients' pre- and postoperatively rated health and daily quality of recovery during the seven days of admission. Furthermore, patients' symptoms, levels of pain, and use of analgesics will be assessed 30 days and six months after discharge.
This study includes one main study and two sub-studies. The main study and sub-study 1a are both prospective observational cohort studies. Study 1b is a qualitative study that includes semi-structured interviews with the included patients. No formal sample size calculation was performed, as the study method is exploratory.
Location of the study This study will be conducted at the Department of Transplantation and Organ Surgery at Copenhagen University Hospital, Rigshospitalet, Denmark, from October 1, 2025, to October 1, 2026. Study 1b will be performed by phone.
Participants The participants will include patients undergoing major hepatic surgery, surgery in the esophagus or cardia, or major surgery on the pancreas performed at Rigshospitalet.
Inclusion criteria Patients must meet the following criteria to be suitable for inclusion in the study.
Patients > 18 years undergoing elective primary surgical treatment according to the protocol with curative intent. Patients who can read and understand the Danish language.
Exclusion criteria Patients meeting one or more of the following criteria are ineligible for inclusion in this study.
Patients who are cognitively disabled and cannot mentally cooperate with the study design, as assessed by the investigator.
Procedure for patients who withdraw from the trial In accordance with the Declaration of Helsinki 24, patients have the right to withdraw from the study at any time for any reason, but the reason must be recorded in the patient's Case Report Form if the cause is known.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 350 observational studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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Patients who have undergone surgery in the pancreas, hepar or esophagus/cardia at Copenhagen University Hospital, Rigshospitalet
Exclusion Criteria:
In accordance with the Declaration of Helsinki, patients have the right to withdraw from the study at any time for any reason
Located in the liver
Procedure: cancer surgery
Located in the esophagus or stomach
Procedure: cancer surgery
Located in the pancreas
Procedure: cancer surgery
All surgery will be performed at Copenhagen University Hospital, Rigshospitalet, Denmark
Median use of analgesics and opioids from the day of surgery until day seven after surgery
All analgesics provided from the day of surgery until seven days after surgery, calculated in median/means for the different surgical groups
Time frame: 7 days
Patients' preoperative expectations
Patients' preoperative expectations evaluated by the treatment expectation questionnaire (TEX-Q. The questionnaire contains 15 questions where the patient can rate their expectations from 0 to ten. 0 is no relief, no benefit or no improvement, and ten represents the opposite. Maximum score is 130 indicating very high expectations.
Time frame: At inclusion
Daily pain measured by the patients
Patients will be asked to measure pain during rest and mobilisation, and the location of the pain. Pain will be rated by the Numeric Rating Scale from 0 to ten. 0 is no pain and ten is the worst imaginable pain
Time frame: From the day of surgery until the seventh day after surgery
Fulfillment of patients´ expecations
Explore in which terms the patients´ expectations were fulfilled by interviewing the patients. We will use a semi-structured interview guide for this purpose.
Time frame: 30 days after admission
The development of chronic pain
We will interview the patients by phone and ask them to rate their pain and if they are still using analgesics. The pain will be rated by the Numeric Rating Scale from 0 to ten. 0 is no pain and ten is the worst imaginable pain. The analgesics will be mapped according to name and frequency used
Time frame: Six months after admission
Postoperative quality of recovery
The patients will be asked to fill out the QoR-15D questionnaire to rate their postoperative quality of recovery. The questionnaire contains 15 questions with a part A which rates every question from 0 indicating at no point to 10 all the time. Part B is the opposite. A high score indicates a good recovery and the score ranges from 0 to 150.
Time frame: The day of surgery until the seventh day after surgery
Health-related quality of life
The patients will be asked to fill out the questionnaire EQ-5D-5L to measure health-related quality of life. The questionnaire contains five areas; ability to move, personal care, activities, pain and anxiety/depression. Every arera can be rated in five different ways differing from no problems to it is not possible to perform activities, extreme pain or anxiety. Finally the questionnaire includes a scale from 0 indicating the worst health you can imagine to 100 indicating the very best. The patient should place an X on the number indicating the self-evaluated health
Time frame: Preoperatively and 30 days and six months after discharge
Level of Pain Catastrophizing
The PCS (Pain Catastrophizing Scale) will be used for this purpose. The PCS is a 13-item self-report questionnaire designed to measure catastrophic thinking related to pain. Each item is rated on a 5-point scale: 0: Not at all, 1: To a slight degree, 2: To a moderate degree, 3: To a great degree, 4: All the time. The total PCS score ranges from 0 to 52, with higher scores indicating greater levels of pain catastrophizing. Scores ≥30 are considered to reflect a clinically relevant level of catastrophizing and correspond to the 75th percentile in chronic pain clinic populations. Scores between the 50th and 75th percentile (typically 20-29) indicate moderate risk, while scores above 30 suggest high risk for persistent pain and disability.
Time frame: preoperatively
Patient's perceived quality of recovery
The patient's perceived quality of recovery will be monitored using the QoR-15D. The score ranges from 0 to 15025,26. An excellent quality will be considered for numbers from 136-150. Good quality for 122-135. Moderate quality: 90-121; poor quality: 0-89. Health-related quality of life will be collected preoperatively and at 30 days (+/-7 days) postoperatively using the EQ-5D-5L. The EQ-5D-5L uses five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels: 1. No problems. 2. Slight problems. 3. Moderate problems. 4. Severe problems. 5. Extreme problems (or unable to do).
Time frame: The day of surgery until day seven after surgery
No study locations are listed for this record.
Plan to share: No — I do not need to share the IPD with other researchers
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Rigshospitalet, Denmark