A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity,Clinical Gastroenterology and Hepatology

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A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity
Clinical Gastroenterology and Hepatology ( IF 11.6 ) Pub Date : 2022-09-06 , DOI: 10.1016/j.cgh.2022.08.034
Nikhil R Thiruvengadam ₁ , Abdul Kouanda ₂ , Anita Kalluri ₃ , Douglas Schaubel ₄ , Monica Saumoy ₅ , Kimberly Forde ₆ , Jun Song ₇ , Alec Faggen ₂ , Brenton G Davis ₂ , Kenechukwu Chudy Onwugaje ₃ , Gregory Cote ₈ , Mustafa A Arain ₉ , Michael L Kochman ₁₀

Affiliation

Division of Gastroenterology and Hepatology, Loma Linda University Health, Loma Linda, California; Division of Gastroenterology and Hepatology, Perelman School of Medicine, Philadelphia, Pennsylvania; Center for Endoscopic Innovation, Research and Training, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
Division of Gastroenterology and Hepatology, UCSF Medical Center, San Francisco, California.
Division of Gastroenterology and Hepatology, Perelman School of Medicine, Philadelphia, Pennsylvania.
Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania.
Center for Digestive Health, Penn Medicine Princeton Medical Center, Plainsboro, New Jersey.
Department of Gastroenterology and Hepatology, Temple University, Philadelphia, Pennsylvania.
Department of Medicine, Temple University, Philadelphia, Pennsylvania.
Division of Gastroenterology and Hepatology, Oregon Health Sciences University, Portland, Oregon.
Division of Gastroenterology and Hepatology, UCSF Medical Center, San Francisco, California; Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida.
Division of Gastroenterology and Hepatology, Perelman School of Medicine, Philadelphia, Pennsylvania; Center for Endoscopic Innovation, Research and Training, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.

Background & Aims

The Cotton Consensus (CC) criteria for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) may not capture post-ERCP morbidity. PAN-PROMISE, a patient-reported outcome measure (PROM), was developed to quantify acute pancreatitis-related morbidity. This study aims to determine the value of PAN-PROMISE in independently defining ERCP-related morbidity.

Methods

We conducted a prospective cohort study of patients undergoing ERCP at 2 academic centers from September 2021 to August 2022. We administered PAN-PROMISE and assessed quality of life and work productivity at baseline, 48 to 72 hours, 7 days, and 30 days following ERCP. PEP was defined by a 3-physician committee using the CC criteria. We defined high morbidity following ERCP (elevated PROM) by an increase of PAN-PROMISE score of >7 at 7 days post-procedure. The McNemar test assessed discordance between PEP and elevated-PROM.

Results

A total of 679 patients were enrolled. Choledocholithiasis (30%) and malignant biliary obstruction (29%) were the main indications for ERCP. Thirty-two patients (4.7%) developed PEP. One hundred forty-seven patients (21.6%) had an elevated PROM, whereas only 20 of them (13.4%) had PEP by the CC criteria (P < .001 for discordance). An elevated PROM strongly correlated with lower physical quality of life and increased direct and indirect health care costs ($80 and $25 per point increase in PAN-PROMISE, respectively). Patients with pancreatic cancer (odds ratio, 4.52; 95% confidence interval, 1.68–10.74) and primary sclerosing cholangitis (odds ratio, 1.79; 95% confidence interval, 1.29–2.45) had the highest odds of elevated PROM.

Conclusions

A substantial number of patients experience significant morbidity after ERCP despite not developing PEP or other adverse events. Future studies are needed to characterize better the reasons behind this increase in symptoms and potential interventions to reduce the symptom burden post-ERCP. ClinicalTrials.gov number, NCT05310409.

中文翻译：

一项评估 PAN-PROMISE 的前瞻性队列研究，PAN-PROMISE 是一种用于检测 ERCP 后发病率的患者报告结果测量

背景与目标

内镜逆行胰胆管造影术 (ERCP) 后胰腺炎 (PEP) 的棉花共识 (CC) 标准可能无法捕捉 ERCP 后发病率。PAN-PROMISE 是一种患者报告的结果测量 (PROM)，旨在量化急性胰腺炎相关的发病率。本研究旨在确定 PAN-PROMISE 在独立定义 ERCP 相关发病率方面的价值。

方法

我们对 2021 年 9 月至 2022 年 8 月在 2 个学术中心接受 ERCP 的患者进行了一项前瞻性队列研究。我们实施了 PAN-PROMISE，并评估了基线、ERCP 后 48 至 72 小时、7 天和 30 天的生活质量和工作效率. PEP 由 3 名医师组成的委员会使用 CC 标准定义。我们通过在术后 7 天 PAN-PROMISE 评分增加 >7 来定义 ERCP（升高的 PROM）后的高发病率。McNemar 测试评估了 PEP 和升高的 PROM 之间的不一致性。

结果

共有 679 名患者入组。胆总管结石 (30%) 和恶性胆道梗阻 (29%) 是 ERCP 的主要指征。32 名患者 (4.7%) 出现 PEP。147 名患者 (21.6%) 的 PROM 升高，而其中只有 20 名 (13.4%) 符合 CC 标准的 PEP（不一致P < .001）。升高的 PROM 与较低的身体生活质量以及增加的直接和间接医疗保健成本密切相关（PAN-PROMISE 每增加一点分别为 80 美元和 25 美元）。胰腺癌患者（比值比为 4.52；95% 置信区间为 1.68-10.74）和原发性硬化性胆管炎患者（比值比为 1.79；95% 置信区间为 1.29-2.45）的 PROM 升高的比值最高。