Pancreatic CancerNCT06254430
Effects of Erector Spina Plan Block and Epidural Analgesia in Whipple Surgery
An observational study of Pancreatic Cancer, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Pancreatic surgery is generally a high-risk and difficult to manage perioperatively. surgery. In pancreatic surgery, in addition to general anaesthesia, central blocks for analgesia and peripheral blocks are also preferred. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- Type of treatment
- Injection or infusion
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2023to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who will have whipple surgery operation under general anesthesia in Ankara Bilkent City Hospital Operating Room,between the ages of 18-80,both genders and in the ASA (The American Society of Anesthesiologists) 1,2,3 risk grup will be included in the study.
Who may be able to join
- Patients undergoing whipple surgery,
- ASA (The American Society of Anesthesiologists) I-III risk grup
- Between the ages of 18-80
Who cannot join
- Those who do not accept the transaction,
- Serious cardiovascular disease,
- Those for whom epidural anesthesia and peripheral blocks are contraindicated,
- Those who have had spinal surgery,
- Those who are allergic to one of the local anesthetics to be used,
- Those whose hemoglobin value is below 10 g/dl) disease,
- Those with drug and alcohol addiction,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06100
About this study
Pancreatic surgery is generally a high-risk and difficult to manage perioperatively.
surgery. In pancreatic surgery, in addition to general anaesthesia, central blocks for analgesia and peripheral blocks are also preferred. In this study, in patients undergoing whipple surgery epidural and erector spina plan block (ESP) may cause intraoperative and postoperative pain, renal functions and haemodynamic variables.
Read the detailed description
Pancreatic surgery and anaesthetic management is a difficult operation due to the anatomical location and function of the pancreas. Thoracic epidural anaesthesia/analgesia (TEA) in addition to general anaesthesia in upper abdominal surgeries such as pancreas, liver and stomach.Thoracic epidural analgesia (TEA) is the most widely used gold standard in this type of surgery.
TEA may cause haemodynamic changes in patients due to decreased sympathetic tone due to sympathetic nerve blockade. In elderly patients, bradycardia and hypotension is observed more frequently. Cardiovascular response decreases with age due to decreased cardiac reserve and deterioration of the autonomic nervous system and arteriolar structure. This can lead to this is because more segments are blocked than in younger patients. Pain control with thoracic epidural will provide pulmonary rehabilitation and rapid mobilisation. Accordingly, thromboembolic events, atelectasis and pulmonary infections are prevented. However, it has important unwanted side effects such as hypotension, dural puncture and contralateral block. All these disadvantages of TEA has increased interest in alternatives. Peripheral regional anaesthesia techniques have become more popular as a component of multimodal analgesia to avoid complications associated with epidural analgesia.
In 2016, ESP block, which is an ultrasound-controlled fascial plane block, was described. ESP block is considered to be an easier, effective and safer alternative to epidural and paravertebral blocks. The mechanism of action of ESP involves blockade of both dorsal and ventral branches, resulting in somatic and visceral analgesia.
Intraoperative and postoperative renal function may be impaired in upper abdominal surgeries. Acute kidney injury (AKI) is an important cause of postoperative mortality and morbidity. The most serious adverse factor is both surgical and anaesthesia-related AKI.
hypotension that may develop. The duties of the anaesthesiologist include maintaining perioperative renal function, predetermining the risk of AKI and taking necessary precautions. Considering the data in the literature, postoperative AKI Recent studies have shown that there is a link between inflammation and cancer. Studies reveal a relationship between cytokine and chemokine production and tumour growth, angiogenesis and metastatic capacity. Inflammatory cells and substances produced by inflammation affect cells in the peripheral blood. Platelets promote extravasation of circulating tumour cells. Neutrophils can also promote tumour adhesion and seeding by secreting growth factors into the peripheral circulation. However, lymphocytes can exert anti-tumour effects by inhibiting the proliferation and migration of tumour cells. From this point of view, SII (Systemic inflammation index) is a new prognostic factor obtained by measuring the number and ratio of neutrophils, platelets and lymphocytes in the peripheral blood of many tumours.
In this study, the effects of epidural analgesia and ESP block on intraoperative opioid requirement and postoperative pain scores, as well as perioperative renal parameters, haemodynamic data and SII (Systemic inflammation index) were investigated and the alternative of ESP block to epidural analgesia was investigated.
- Conditions
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia | The patients were fasted for 8 hours before the operation without premedication. The patient was taken to the operation room. In all cases, a vein on the back of the hand was cannulated for peripheral venous catheter was cannulated from the back of the hand. Standard monitoring was applied. In the epidural group, 42 patients received a standard 18 G injection at the appropriate level between T8 and T10. The epidural space was entered by loss of resistance method with touchy needle. 15 µg in 3 mL saline The test dose was administered by administering epinephrine. Then the epidural catheter was inserted towards the cranium. was advanced five cm. Bupivacaine 0.25% was started as infusion through the catheter. Since the mean arterial pressure dropped below 60 mm/hg in 5 patients, epidural infusion was stopped and inotropic treatment was started. | |
| Erector Spina Plan(ESP) Block | Esp group included 28 patients in the preoperative operating theatre between T8 and T10 1 hour before the operation. level, the USG (ultrasonography) probe is placed in the midline in the cephalocaudal direction and then the USG (ultrasonography) probe is placed approximately 3 cm laterally over the transverse processes and transverse with the erector spinae muscle 0.25 % bupivacaine 20 cc each in the fascial plane between the processes bilateral thoracic erector spina block and then 50 mg dexketoprofen before surgery implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentayl consumption (microgram)
Total amount of remifentanyl during the Intraoperative period
Measured: peroperatively
Postoperative visual analog scale(1-10)
the investigators aimed to compare postoperative visual analog scale of two groups.The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain 10 indicates severe pain
Measured: at the postoperative 1. hour
Rate of heart beat (beat/min)
the investigators aimed to compare intraoperative pulse rate of two groups
Measured: During the anesthesia, It will be evaluated at 1 hour intervals.
Value of systolic blood pressure (mmHg)
the investigators aimed to compare intraoperative systolic blood pressure of two groups
Measured: During the anesthesia, It will be evaluated at 1 hour intervals.
Rate of systemic inflammation index: SII (Systemic immune inflammatory index) is the formulation of the values of platelets, neutrophils and lymphocytes in peripheral blood as P X N / L = SII.
the investigators aimed to compare postoperative systemic inflammation index of two groups.
Measured: At the preoperative and postoperative time points
Secondary outcomes (3)
Amount of postoperative creatinine (mg/dl)
the investigators aimed to compare postoperative creatine of two groups
Measured: At the postoperative 24.hour
Amount of postoperative urea (mg/L)
It will be aimed to compare postoperative urea of two groups
Measured: at the postoperative 24.hour
incidence of death (percentage of )
the investigators aimed to compare postoperative mortality of two groups
Measured: at postoperative 1.year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start20 Mar 2023
- Primary completion20 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Özcan, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254430
- Sponsor's protocol ID
- E2-22-1596
- Status last verified
- Feb 2024
- First submitted
- 19 Dec 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Walter CM, Lee CS, Moore DL, Abbasian N, Clay SJ, Mecoli MD, Olbrecht VA, Batra M, Ding L, Yang F, Nair M, Huq A, Simpson BE, Brown RL, Garcia VF, Chidambaran V. Retrospective study comparing outcomes of multimodal epidural and erector spinae catheter pain protocols after pectus surgery. J Pediatr Surg. 2023 Mar;58(3):397-404. doi: 10.1016/j.jpedsurg.2022.06.017. Epub 2022 Jul 6.
PubMed 35907711Putowski Z, Majewska K, Gruca K, Zimnoch A, Szczepanska A, Krzych LJ, Jablonska B, Mrowiec S. Intraoperative Hypotension and Its Association with Postoperative Acute Kidney Injury in Patients Undergoing Pancreaticoduodenectomy: A 5-Year, Single-Center, Retrospective Cohort Study. Med Sci Monit. 2023 Apr 11;29:e938945. doi: 10.12659/MSM.938945.
PubMed 37038338Viderman D, Tapinova K, Nabidollayeva F, Tankacheev R, Abdildin YG. Intravenous versus Epidural Routes of Patient-Controlled Analgesia in Abdominal Surgery: Systematic Review with Meta-Analysis. J Clin Med. 2022 May 5;11(9):2579. doi: 10.3390/jcm11092579.
PubMed 35566705Jipa M, Isac S, Klimko A, Simion-Cotorogea M, Martac C, Cobilinschi C, Droc G. Opioid-Sparing Analgesia Impacts the Perioperative Anesthetic Management in Major Abdominal Surgery. Medicina (Kaunas). 2022 Mar 28;58(4):487. doi: 10.3390/medicina58040487.
PubMed 35454326Nair A, Saxena P, Borkar N, Rangaiah M, Arora N, Mohanty PK. Erector spinae plane block for postoperative analgesia in cardiac surgeries- A systematic review and meta-analysis. Ann Card Anaesth. 2023 Jul-Sep;26(3):247-259. doi: 10.4103/aca.aca_148_22.
PubMed 37470522Zhang Y, Chong JH, Harky A. Enhanced recovery after cardiac surgery and its impact on outcomes: A systematic review. Perfusion. 2022 Mar;37(2):162-174. doi: 10.1177/0267659121988957. Epub 2021 Jan 19.
PubMed 33468017Chen Q, Ren S, Cui S, Huang J, Wang D, Li B, He Q, Lang R. Prognostic and recurrent significance of SII in patients with pancreatic head cancer undergoing pancreaticoduodenectomy. Front Oncol. 2023 May 22;13:1122811. doi: 10.3389/fonc.2023.1122811. eCollection 2023.
PubMed 37284203Canikli Adiguzel S, Akyurt D, Bahadir Altun H, Tulgar S, Ultan Ozgen G. Can Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio, or Systemic Immune Inflammation Index Be an Indicator of Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy? Cureus. 2023 Jan 19;15(1):e33955. doi: 10.7759/cureus.33955. eCollection 2023 Jan.
PubMed 36820108
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Erector Spina Plan Block and Epidural Analgesia in Whipple Surgery
- ClinicalTrials.gov ID
- NCT06254430
- Acronym / sponsor ID
- E2-22-1596
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic surgery is generally a high-risk and difficult to manage perioperatively.
surgery. In pancreatic surgery, in addition to general anaesthesia, central blocks for analgesia and peripheral blocks are also preferred. In this study, in patients undergoing whipple surgery epidural and erector spina plan block (ESP) may cause intraoperative and postoperative pain, renal functions and haemodynamic variables.
Detailed description
Pancreatic surgery and anaesthetic management is a difficult operation due to the anatomical location and function of the pancreas. Thoracic epidural anaesthesia/analgesia (TEA) in addition to general anaesthesia in upper abdominal surgeries such as pancreas, liver and stomach.Thoracic epidural analgesia (TEA) is the most widely used gold standard in this type of surgery.
TEA may cause haemodynamic changes in patients due to decreased sympathetic tone due to sympathetic nerve blockade. In elderly patients, bradycardia and hypotension is observed more frequently. Cardiovascular response decreases with age due to decreased cardiac reserve and deterioration of the autonomic nervous system and arteriolar structure. This can lead to this is because more segments are blocked than in younger patients. Pain control with thoracic epidural will provide pulmonary rehabilitation and rapid mobilisation. Accordingly, thromboembolic events, atelectasis and pulmonary infections are prevented. However, it has important unwanted side effects such as hypotension, dural puncture and contralateral block. All these disadvantages of TEA has increased interest in alternatives. Peripheral regional anaesthesia techniques have become more popular as a component of multimodal analgesia to avoid complications associated with epidural analgesia.
In 2016, ESP block, which is an ultrasound-controlled fascial plane block, was described. ESP block is considered to be an easier, effective and safer alternative to epidural and paravertebral blocks. The mechanism of action of ESP involves blockade of both dorsal and ventral branches, resulting in somatic and visceral analgesia.
Intraoperative and postoperative renal function may be impaired in upper abdominal surgeries. Acute kidney injury (AKI) is an important cause of postoperative mortality and morbidity. The most serious adverse factor is both surgical and anaesthesia-related AKI.
hypotension that may develop. The duties of the anaesthesiologist include maintaining perioperative renal function, predetermining the risk of AKI and taking necessary precautions. Considering the data in the literature, postoperative AKI Recent studies have shown that there is a link between inflammation and cancer. Studies reveal a relationship between cytokine and chemokine production and tumour growth, angiogenesis and metastatic capacity. Inflammatory cells and substances produced by inflammation affect cells in the peripheral blood. Platelets promote extravasation of circulating tumour cells. Neutrophils can also promote tumour adhesion and seeding by secreting growth factors into the peripheral circulation. However, lymphocytes can exert anti-tumour effects by inhibiting the proliferation and migration of tumour cells. From this point of view, SII (Systemic inflammation index) is a new prognostic factor obtained by measuring the number and ratio of neutrophils, platelets and lymphocytes in the peripheral blood of many tumours.
In this study, the effects of epidural analgesia and ESP block on intraoperative opioid requirement and postoperative pain scores, as well as perioperative renal parameters, haemodynamic data and SII (Systemic inflammation index) were investigated and the alternative of ESP block to epidural analgesia was investigated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia | – | –The patients were fasted for 8 hours before the operation without premedication. The patient was taken to the operation room. In all cases, a vein on the back of the hand was cannulated for peripheral venous catheter was cannulated from the back of the hand. Standard monitoring was applied. In the epidural group, 42 patients received a standard 18 G injection at the appropriate level between T8 and T10. The epidural space was entered by loss of resistance method with touchy needle. 15 µg in 3 mL saline The test dose was administered by administering epinephrine. Then the epidural catheter was inserted towards the cranium. was advanced five cm. Bupivacaine 0.25% was started as infusion through the catheter. Since the mean arterial pressure dropped below 60 mm/hg in 5 patients, epidural infusion was stopped and inotropic treatment was started. |
| Erector Spina Plan(ESP) Block | – | –Esp group included 28 patients in the preoperative operating theatre between T8 and T10 1 hour before the operation. level, the USG (ultrasonography) probe is placed in the midline in the cephalocaudal direction and then the USG (ultrasonography) probe is placed approximately 3 cm laterally over the transverse processes and transverse with the erector spinae muscle 0.25 % bupivacaine 20 cc each in the fascial plane between the processes bilateral thoracic erector spina block and then 50 mg dexketoprofen before surgery implemented. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will have whipple surgery operation under general anesthesia in Ankara Bilkent City Hospital Operating Room,between the ages of 18-80,both genders and in the ASA (The American Society of Anesthesiologists) 1,2,3 risk grup will be included in the study.
Key inclusion criteria (3 listed)
- Patients undergoing whipple surgery,
- ASA (The American Society of Anesthesiologists) I-III risk grup
- Between the ages of 18-80
Key exclusion criteria (7 listed)
- Those who do not accept the transaction,
- Serious cardiovascular disease,
- Those for whom epidural anesthesia and peripheral blocks are contraindicated,
- Those who have had spinal surgery,
- Those who are allergic to one of the local anesthetics to be used,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative remifentayl consumption (microgram)
Time frame: peroperatively
Total amount of remifentanyl during the Intraoperative period
Postoperative visual analog scale(1-10)
Time frame: at the postoperative 1. hour
the investigators aimed to compare postoperative visual analog scale of two groups.The visual pain scale is measured with a ruler from 0 to 10 cm. 0 indicates no pain 10 indicates severe pain
Rate of heart beat (beat/min)
Time frame: During the anesthesia, It will be evaluated at 1 hour intervals.
the investigators aimed to compare intraoperative pulse rate of two groups
Value of systolic blood pressure (mmHg)
Time frame: During the anesthesia, It will be evaluated at 1 hour intervals.
the investigators aimed to compare intraoperative systolic blood pressure of two groups
Rate of systemic inflammation index: SII (Systemic immune inflammatory index) is the formulation of the values of platelets, neutrophils and lymphocytes in peripheral blood as P X N / L = SII.
Time frame: At the preoperative and postoperative time points
the investigators aimed to compare postoperative systemic inflammation index of two groups.
3 secondary outcomes
Amount of postoperative creatinine (mg/dl)
Time frame: At the postoperative 24.hour
Amount of postoperative urea (mg/L)
Time frame: at the postoperative 24.hour
incidence of death (percentage of )
Time frame: at postoperative 1.year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 35907711Walter CM, Lee CS, Moore DL, Abbasian N, Clay SJ, Mecoli MD, Olbrecht VA, Batra M, Ding L, Yang F, Nair M, Huq A, Simpson BE, Brown RL, Garcia VF, Chidambaran V. Retrospective study comparing outcomes of multimodal epidural and erector spinae catheter pain protocols after pectus surgery. J Pediatr Surg. 2023 Mar;58(3):397-404. doi: 10.1016/j.jpedsurg.2022.06.017. Epub 2022 Jul 6.
- Background: PubMed 37038338Putowski Z, Majewska K, Gruca K, Zimnoch A, Szczepanska A, Krzych LJ, Jablonska B, Mrowiec S. Intraoperative Hypotension and Its Association with Postoperative Acute Kidney Injury in Patients Undergoing Pancreaticoduodenectomy: A 5-Year, Single-Center, Retrospective Cohort Study. Med Sci Monit. 2023 Apr 11;29:e938945. doi: 10.12659/MSM.938945.
- Background: PubMed 35566705Viderman D, Tapinova K, Nabidollayeva F, Tankacheev R, Abdildin YG. Intravenous versus Epidural Routes of Patient-Controlled Analgesia in Abdominal Surgery: Systematic Review with Meta-Analysis. J Clin Med. 2022 May 5;11(9):2579. doi: 10.3390/jcm11092579.
- Background: PubMed 35454326Jipa M, Isac S, Klimko A, Simion-Cotorogea M, Martac C, Cobilinschi C, Droc G. Opioid-Sparing Analgesia Impacts the Perioperative Anesthetic Management in Major Abdominal Surgery. Medicina (Kaunas). 2022 Mar 28;58(4):487. doi: 10.3390/medicina58040487.
- Background: PubMed 37470522Nair A, Saxena P, Borkar N, Rangaiah M, Arora N, Mohanty PK. Erector spinae plane block for postoperative analgesia in cardiac surgeries- A systematic review and meta-analysis. Ann Card Anaesth. 2023 Jul-Sep;26(3):247-259. doi: 10.4103/aca.aca_148_22.
- Background: PubMed 33468017Zhang Y, Chong JH, Harky A. Enhanced recovery after cardiac surgery and its impact on outcomes: A systematic review. Perfusion. 2022 Mar;37(2):162-174. doi: 10.1177/0267659121988957. Epub 2021 Jan 19.
- Background: PubMed 37284203Chen Q, Ren S, Cui S, Huang J, Wang D, Li B, He Q, Lang R. Prognostic and recurrent significance of SII in patients with pancreatic head cancer undergoing pancreaticoduodenectomy. Front Oncol. 2023 May 22;13:1122811. doi: 10.3389/fonc.2023.1122811. eCollection 2023.
- Background: PubMed 36820108Canikli Adiguzel S, Akyurt D, Bahadir Altun H, Tulgar S, Ultan Ozgen G. Can Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio, or Systemic Immune Inflammation Index Be an Indicator of Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy? Cureus. 2023 Jan 19;15(1):e33955. doi: 10.7759/cureus.33955. eCollection 2023 Jan.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative remifentayl consumption (microgram) (time frame: peroperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06254430, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.