An interventional study of EUSRA RFA needle in Pancreatic Cancer, Pancreatic Neoplasms and Pancreatic Adenocarcinoma, sponsored by Singapore General Hospital. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-02-20.
Sponsored by Singapore General Hospital · Not applicable, Interventional, and Treatment
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Among 36 studies in Pancreatic Neoplasms with a site in Singapore — 6 open to participants now, 11 under way, 2 of them phase 3. Pancreatic Neoplasms · Singapore.
Among the 36 studies in Pancreatic Neoplasms with a site in Singapore, this one is the 30th largest by planned enrollment of the 30 interventional ones that give a count, is one of 2 that started in 2018, is the only one with no phase, and was the 23rd registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,006 are open to participants now.
Browse Pancreatic Neoplasms studies →6 of the 36 studies in Pancreatic Neoplasms with a site in Singapore are open now. Recruiting first, the newest first:
Revolution Medicines, Inc. · Sites in Singapore, United States, Australia and 13 more countries
Ages 18+
National Cancer Centre, Singapore · Sites in Singapore
Ages 21–99
MiRXES Pte Ltd · Sites in Singapore
Ages 21+ · Healthy volunteers
Arbor Research Collaborative for Health · Sites in Singapore, United States, Australia and 9 more countries
Ages 18–90 · Healthy volunteers
Apollomics Inc. · Sites in Singapore, United States, Australia and 8 more countries
Ages 18+
A study can be open while its sites in Singapore have not opened yet or have stopped. Only those recruiting at a site in Singapore →
Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 21 Years to 99 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
36 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 15 · Phase 3 8 · Phase 4 1
First in 2001; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 10 is below the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Median enrollment 190 across the 30 interventional studies, 1,000 across the 5 observational. Of the 21 that completed or were terminated, 11 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 36 have an industry lead sponsor. The 10 most frequent:
Singapore General Hospital is the lead sponsor of 270 studies on the registry; 57 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Singapore General Hospital has 2 studies filed under Pancreatic Neoplasms — fewer than ten, so there is no comparison to draw.
4 of the studies in Pancreatic Neoplasms with a site in Singapore that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02912949Partner Therapeutics, Inc.A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy) | 2026-12-31 |
| NCT05929885National Cancer Centre, SingaporeMetronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients | 2027-02-28 |
| NCT05462717Revolution Medicines, Inc.Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors | 2027-03-31 |
| NCT02568267Hoffmann-La RocheBasket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) | 2027-06-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 36 studies in Pancreatic Neoplasms with a site in Singapore, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to evaluate the safety and efficacy of new ablation catheter developed by MEDICAL TAEWOONG for the treatment of pancreatic neoplasm (pancreatic adenocarcinoma or neuroendocrine tumour). The ablation is performed using EUSRA needle and radio frequency waves under ultrasound imaging. The subject who will be recruited into this study are patients who are deemed as non-surgical candidates.
RFA causes tissue destruction through the application of a high frequency alternating current, generating local temperatures above 60°C and leading to coagulative necrosis. The technique has been widely used in many solid organ tumours and has been shown to result in 5-year survival rates comparable to surgery. The technique is currently the standard therapy in hepatocellular carcinoma and colorectal pulmonary metastasis particular in patients that are not suitable for surgery.
The application of RFA in the pancreas was first described in 1999. Thereafter, several studies performed in the porcine model demonstrated the feasibility of RFA under EUS guidance. In the first porcine study by Goldberg et al, RFA was applied through a modified 19 gauge Vilmann-type needle (GIP/MediGlobe, Grassau, Germany). The needles were electrically insulated with shrink tubing for all but the distal 1 to 1.5cm. 16 ablations were performed and the procedure resulted in hypodense foci of non-enhancing pancreas 1 to 2 days after ablation. Pathologic examination showed well demarcated spherical foci of coagulation necrosis measuring 8 to 12mm in size. One swine developed hyperlipasemia, a focal zone of pancreatitis and another with pancreatic fluid collection. 4 swine also suffered from thermal injury to the gastrointestinal wall caused by improper electrode placement.
Thereafter, 4 subsequent porcine studies also demonstrated the feasibility of RFA under EUS guidance with proprietary radiofrequency electrodes. In the most recent study, EUS-guided RFA was delivered by a novel 18-gauge RFA electrode and a VIVA RF generator (STARmed, Korea). RFA was applied to both the ex-vivo and in-vivo models to determine the optimum power settings and efficacy of the device. A power setting of 50 W for 6 minutes was shown to result in the most effective depth and size of ablation zone, whilst a higher power setting resulted in tissue charring and reduced the conductive coagulative necrosis effect. 10 swine then received EUS-guided RFA to the pancreas and the mean size of the ablated lesions were 23 +/- 6.9mm. None of the swine suffered from any adverse events and there were no significant changes in the serum levels of amylase and lipase, both before and after the procedures.
On the other hand, the experience of RFA in human pancreas is accumulating. Earlier studies using first generation percutaneous RFA probes applied intra-operatively to pancreatic carcinomas were associated with unacceptably high rates of mortality (0% - 25%) and morbidity (0% - 40%). Subsequently, human data on new generation EUS-guided RFA probes with improved design and outcomes have become available. 22 patients with locally advanced pancreatic ductal adenocarcinoma were treated the cryotherm probe (CTP) (ERBE Elektromedizin GmbH, Tübingen, Germany). The CTP was successfully applied in 16 patients (72.8%), amylase rose in 3 of 16 patients but none had clinical signs of pancreatitis. The median post ablation survival time was 6 months. In another 2 studies, the Habib RFA catheter was used (EMcision, United Kingdom). 7 patients with unresectable pancreatic ductal carcinoma and 8 patients with pancreatic neuroendocrine tumour and cystic tumours were treated with EUS-guided RFA. In patients suffering from pancreatic ductal carcinoma, post procedural imaging showed a decrease in size of the lesions in 2 patients and 1 patient suffered from mild pancreatitis. Whilst in patients with cystic neoplasms and neuroendocrine tumours, all showed complete resolution or reduction in size of the lesions. Only 2 patients suffered from abdominal pain that resolved spontaneously. On the other hand, RFA with the VIVA generator was applied in 6 patients with unresectable pancreatic adenocarcinoma. Two patients suffered from mild abdominal pain but no serious adverse events reported.
Thus, based on these preliminary results, we conclude that the new generation EUS-guided RFA probe is safe and feasible. The next stage in development with conduction of this study would involve recruitment of larger patient cohorts to further establish the efficacy and risk profile of the procedure.
HYPOTHESIS AND OBJECTIVES The aim of the current study is to perform a single center prospective study on EUS-guided radiofrequency ablation (RFA) of solid pancreatic neoplasms. We hypothesize that EUS-guided RFA is safe, feasible and effective for treating solid pancreatic neoplasms.
EXPECTED RIKS AND BENEFITS The expected risks for the patients include mild abdominal pain. The benefit may include RFA destroy the tumour cells via coagulative necrosis process hence providing some form of disease control. Besides, the current study could establish the safety and feasibility of EUS-guided RFA of solid pancreatic neoplasms. These results could provide insights as to whether the procedure is comparable to surgery for treatment of these lesions in the future.
STUDY POPULATION We aim to recruit 10 subjects over the period of 18 months. The subjects must have pancreatic neuroendocrine tumour or pancreatic ductal carcinoma that was unsuitable for surgery or not keen for surgery.
STUDY DESIGN AND PROCEDURES/METHODOLOGY The RFA system It consists of two components, a19-gauge RFA electrode and a VIVA combo RF generator. The total length of the electrode including the delivery system is 150 cm. The distal end of the electrode is needle-shaped and echogenic that allows EUS guided puncture of the target lesion. The active electrode tip is 1 cm in length. During ablation, the RF electrode is cooled and perfused internally with circulating chilled saline solution (0°C) delivered via a pump to maintain a constant temperature. A setting of 50W energy would be used for RFA and the duration of application is 10 seconds.
EUS-guided radiofrequency ablation This procedure is very similar to the standard technique of EUS-guided fine needle aspiration. The location and size of the lesion would be assessed for suitability of treatment. After locating the lesion, the RFA needle would be inserted to the centre of the lesion. RFA would then be initiated and hyperechoic interferences would be observed around the electrode signifying heating of the tissue. Post procedural, the site of needle entry would be inspected endoscopically to assess for presence of thermal injury to the gastrointestinal wall.
Follow-up protocol There will be clinic visit scheduled by both gastroenterologist and oncologist at two weeks after discharging from hospital to review participant's condition and to plan for further treatment. Follow-up phone call will be made at 1st week and 1st month after discharging from the ward to determine for any adverse event and whether they are attributable. When reporting complication rates, only definite and probably attributable events occurring within 30 days will be include.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Unsuitable for surgery, due to one (or more) of the following items:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This procedure is very similar to the standard technique of EUS-guided fine needle aspiration. All patients would undergo EUS with a linear array or therapeutic echoendoscope. The location and size of the lesion would be assessed for suitability of treatment. After locating the lesion, the EUSRA RFA needle would be inserted to the centre of the lesion. RFA would then be initiated and hyperechoic interferences would be observed around the electrode signifying heating of the tissue.
Device: EUSRA RFA needle
A 19-gauge RFA electrode and a RF generator with a electrode that is needle-shaped and echogenic that allows EUS guided puncture of the target lesion. The active electrode tip is 1 cm in length. During ablation, the RF electrode is cooled and perfused internally with circulating chilled saline solution (0°C) delivered via a pump to maintain a constant temperature. A setting of 50W energy would be used for RFA and the duration of application is 10 seconds. Sequential applications of up to 7 times per session are allowed for complete ablation of the lesions.
To measure the technical success of EUS-guided RFA
It is defined as successful puncture of the pancreatic lesion with the RFA needle and completion of the ablation cycle.
Time frame: 18 months
To measure side effects and adverse event of EUS-guided RFA
Adverse events specific to RFA would be graded according to the lexicon of endoscopic adverse events (PB Cotton GIE 2010). Potential adverse events specific to RFA include: * Post-RFA syndrome: Combination of flu like symptoms including fever, malaise, pain at the site of ablation, nausea, and/or vomiting and that no other septic source is identified. * Pancreatitis: Clinical presence of abdominal pain with an increase in amylase level \>3 times above the normal serum amylase levels. * Pancreatic leak: The presence of an abdominal collection with an amylase level that is \>3 times normal serum amylase levels. * Thermal injury: Coagulative necrosis occurring at the site of needle entry within the gastrointestinal tract with or without clinical sequelae.
Time frame: 18 months
Plan to share: Yes — IPD on study protocol will be made available
Supporting information: Study protocol
Time frame: 12months after completion
Access criteria: Information will be made available after requestors sign a data assess agreement.
Start is estimated for Mar 2018; primary completion for Sep 2019, 18 months later.
Of 403 non-industry interventional studies with no phase under Pancreatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 75. This study's planned 18 months is below that.
Counting every sponsor, half of 430 studies reached it within 44 months; a quarter within 26 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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