CHARM 2: Chemotherapy for ablation and resolution of mucinous pancreatic cysts: a prospective, randomized, double-blind, multi-center clinical trial
CHARM 2: Chemotherapy for ablation and resolution of mucinous pancreatic cysts: a prospective, randomized, double-blind, multi-center clinical trial
批准号:
10478007
负责人:
John M DeWitt
金额:
$40.97万
依托单位国家:
美国
项目类别:
财政年份:
2018
资助国家:
美国
项目状态:
已结题
起止时间:
2018-08-01 至 2024-07-31
关键词:
Abdominal PainAblationAdmixtureAdultAdverse eventAlcohol consumptionAspirate substanceCancer EtiologyCaringCessation of lifeClinicalCombination Drug TherapyCystCystic LesionDiagnosisDouble-Blind MethodDyesEarly InterventionEndoscopic UltrasonographyEndoscopyEpidemicEthanolExcisionExtravasationFundingGastroenterologyGeneral PopulationHospitalizationImageImaging TechniquesIn complete remissionIncidenceInfusion proceduresInjectionsInterventionInvestigationIrrigationLesionLinkMagnetic Resonance ImagingMalignant - descriptorMalignant NeoplasmsMalignant neoplasm of pancreasMethodsModalityMucinousMulti-Institutional Clinical TrialMulticenter TrialsNeedlesNewly DiagnosedOperative Surgical ProceduresPaclitaxelPancreatectomyPancreatic CystPancreatic cystic neoplasiaPatientsPharmacologyPilot ProjectsPrevalenceProceduresPublic HealthPublishingQualifyingRandomizedRandomized Controlled TrialsRelative RisksResearchResolutionRiskSafetySalineSurgical OncologyTestingTimeTissuesUnited StatesWeightX-Ray Computed Tomographyacute pancreatitisadverse event riskaging populationbasechemotherapeutic agentchemotherapyclinically significantcostdesigneffective therapyexperiencefollow-upgemcitabinehigh riskmalignant breast neoplasmmortalitymultidisciplinarynovelpremalignantprospectivepublic health relevanceradiological imagingrandomized trialstandard of caresuccesstreatment comparisontreatment grouptreatment strategytrial comparingtwo-arm study
中文摘要
难以定性和治疗的癌前胰腺囊肿日益增多
由于成像技术的进步和老龄化,在过去的20年里在美国发现了
人口。随着美国高致命性胰腺癌发病率的上升,干预
具有恶性潜在性的胰腺囊肿是一种安全有效的公共卫生方法
担忧。虽然患者历史上一直局限于放射检查或潜在地
作为处理这些囊肿的不良方法的危险手术,内窥镜超声
引导细针注射(EUS-FNI)是一种创伤小、安全有效的方法
早期干预方法。对于目前EUS引导下的胰腺囊肿治疗,通常情况下
包括用乙醇灌洗。然而,专家们一致认为,观察到的不良事件
在治疗过程中是由于乙醇的使用。最近,基于对周围安全的担忧
乙醇的使用,以及与紫杉醇输注有关的有希望的治疗结果,我们的
该团队创造了一种无乙醇(EF)的联合化疗疗法,由
混合物-紫杉醇和吉西他滨-专门针对胰腺囊性病变而设计
超声引导下注射肿瘤。我们的团队完成了对这种新型治疗策略的测试
2017年作为初步随机试验,显示EF灌洗(即生理盐水)与
与相同的化疗方法相比,化疗同样有效,而且要安全得多
包括乙醇灌洗(EL)。在这项建议中,我们的目的是扩大我们的试点研究的规模,
进行一项大型、明确的多中心试验,这将是第一个资助的随机对照试验
EL转无酒精(EF)联合化疗的治疗
探员们。所有受试者都将接受抽吸和疏散符合条件的囊性病变,并接受
术后3个月复查,12个月复查。我们将随机分配100
成人胰腺囊肿患者分为两个研究组:(1)无水乙醇灌洗(EL):EL,然后
输注紫杉醇-吉西他滨混合液,或(2)无乙醇(EF):生理盐水灌洗
通过输注相同的紫杉醇-吉西他滨混合物。我们假设EF治疗将
显著减少不良事件,并将有完全的囊性消融率
并不逊色于EL治疗。如果外汇储备干预被证明不逊于
比EL治疗安全得多,它将验证EUS-FNI作为一种可行的治疗方式
介入癌前囊肿,将改变胰腺囊肿的护理标准
管理层。关键是,如果EF治疗成功,它可能会改变治疗决定,
患者做出并改变卓越中心提供的治疗选择。
英文摘要
Pre-malignant pancreatic cysts that are difficult to characterize and treat are increasingly
discovered in the US over the last two decades due to advances in imaging and an aging
population. With the incidence of highly lethal pancreatic cancer rising in the US, intervening on
pancreatic cysts with malignant potential in a safe and effective way is a major public health
concern. While patients have been historically limited to radiographic surveillance or potentially
hazardous surgery as undesirable methods of managing these cysts, endoscopic ultrasound
guided fine needle injection (EUS-FNI) has emerged as a less-invasive, safe and effective
method of early intervention. For EUS-guided treatment of pancreatic cysts today, care typically
includes lavage with ethanol. However, experts agree that adverse events (AEs) observed
during treatment are due to ethanol use. Recently, based on the safety concerns surrounding
ethanol use, as well as the promising treatment findings linked to the infusion of paclitaxel, our
team created an ethanol-free (EF), combination chemotherapy treatment consisting of an
admixture—paclitaxel and gemcitabine—specifically designed to target pancreatic cystic
neoplasia by EUS-guided injection. Our team completed testing of this novel treatment strategy
in 2017 as a preliminary randomized trial, showing that EF lavage (i.e., saline) with combination
chemotherapy was as effective, and far safer, than the same chemotherapy treatment with the
inclusion of ethanol lavage (EL). In this proposal, our aim is increase the scale of our pilot study,
conducting a large and definitive multi-center trial that will be the first funded RCT to compare
treatment with EL to ethanol-free (EF) treatment with combination infusion of chemotherapeutic
agents. All subjects will have qualifying cystic lesions aspirated and evacuated, and undergo a
follow-up procedure at 3 months and final imaging at 12 months. We will randomly assign 100
adult patients with pancreatic cysts to two study arms: (1) Ethanol lavage (EL): EL, followed by
infusion of a paclitaxel-gemcitabine admixture, or (2) Ethanol Free (EF): saline lavage, followed
by infusion of the same paclitaxel-gemcitabine admixture. We hypothesize that EF treatment will
result in significantly fewer adverse events and will have complete cyst ablation resolution rates
that are not inferior to EL treatment. If the EF intervention proves to be non-inferior to, and
significantly safer than, treatment with EL, it will validate EUS-FNI as a viable treatment modality
for intervening on pre-malignant cysts and will change the standard of care for pancreatic cyst
management. Critically, if EF treatment is successful, it may alter the treatment decisions that
patients make and change the treatment options that centers of excellence offer.
期刊论文(2)
专著(0)
科研奖励(0)
会议论文
The Durability of EUS-Guided Chemoablation of Mucinous Pancreatic Cysts: A Long-Term Follow-Up of the CHARM trial.
EUS引导的粘液性胰腺囊肿的化疗的耐用性:魅力试验的长期随访。
DOI:
10.1016/j.cgh.2021.03.041
发表时间:
2022-03
期刊:
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
影响因子:
--
作者:
[Lester C, Walsh L, Hartz KM, Mathew A, Levenick JM, Headlee BD, Heisey HD, Birkholz JH, Dixon M, Maranki JL, Gusani NJ, Dye CE, Moyer MT]
通讯作者:
Moyer MT
DOI:
10.1016/j.vgie.2020.07.022
发表时间:
2020-12
期刊:
VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy
影响因子:
--
作者:
[Hartz KM, Dixon MEB, Levenick J, Moyer MT]
通讯作者:
Moyer MT
CHARM 2: Chemotherapy for ablation and resolution of mucinous pancreatic cysts: a prospective, randomized, double-blind, multi-center clinical trial
-
批准号:10002201
-
项目类别:
-
资助金额:$43.15万
-
财政年份:2018
-
负责人:John M DeWitt
-
依托单位:
CHARM 2: Chemotherapy for ablation and resolution of mucinous pancreatic cysts: a prospective, randomized, double-blind, multi-center clinical trial
-
批准号:9750284
-
项目类别:
-
资助金额:$41.34万
-
财政年份:2018
-
负责人:John M DeWitt
-
依托单位:
海外基金