Rectal diclofenac versus indomethacin for prevention of post-ERCP pancreatitis (DIPPP): a multicentre, double-blind, randomised, controlled trial.

The aim of our study was to compare the efficacy of 100 mg rectal indomethacin versus diclofenac on PEP incidences.

我们研究的目的是比较100毫克吲哚美辛直肠给药与双氯芬酸在预防PEP发生率方面的疗效。

Methods

This multicentre, double-blinded, randomised controlled trialwas conducted in nine tertiary centres in China.

这项多中心、双盲、随机对照试验在中国的九个三级中心进行。

Patients with low and high risk for PEP and native papilla were randomly allocated (1:1) to receive 100 mg diclofenac or 100 mg indomethacin rectally before ERCP.

低风险和高风险的PEP患者以及原发性乳头患者被随机分配（1:1），在ERCP前通过直肠接受100毫克的双氯芬酸或100毫克的吲哚美辛。

The primary outcome was the occurrence of PEP defined by the Cotton consensus.

主要结果是根据Cotton共识定义的胰腺炎性反应（PEP）的发生。

The intention-to-treatprinciple was conducted for the analysis.

分析中执行了意向治疗原则。

Results

The trial was terminated early for futility after the predetermined first interim analysis.

在预定的首次中期分析后，由于无效性，该试验被提前终止。

Between June 2023 and May 2024, 1204 patients were randomised into the diclofenac group (n=600) or indomethacin group (n=604).

在2023年6月至2024年5月期间，共有1204名患者被随机分配到双氯芬酸组（n=600）或吲哚美辛组（n=604）。

Baseline characteristics were balanced.

基线特征均衡。

The primary outcome occurred in 53 patients (8.8%) of 600 patients allocated to the diclofenac group and 37 patients (6.1%) of 604 patients allocated to the indomethacin group (relative risk 1.44; 95% CI 0.96 to 2.16, p=0.074).

主要结果发生在被分配到双氯芬酸组的600名患者中的53名患者（8.8%）和被分配到吲哚美辛组的604名患者中的37名患者（6.1%）（相对风险1.44；95%置信区间0.96至2.16，p=0.074）。

PEP occurred in 35 (14.2%) of 247 high-risk patients in the diclofenac group and 26 (9.8%) of 266 high-risk patients in the indomethacin group (p=0.124).

在247名高风险患者中，35名（14.2%）在双氯芬酸组发生了PEP，而在266名高风险患者中，26名（9.8%）在吲哚美辛组发生了PEP（p=0.124）。

PEP incidences were also comparable in low-risk patients between the two groups (18/353 (5.1%) vs 11/338 (3.3%), p=0.227).

在低风险患者中，两组的PEP发生率也相当（双氯芬酸组353名患者中有18名（5.1%），吲哚美辛组338名患者中有11名（3.3%），p=0.227）。

Other ERCP-related complications did not differ between the two groups.

两组之间的其他内镜逆行胰胆管造影（ERCP）相关并发症没有差异。

Conclusions

Pre-procedure 100 mg rectal diclofenac was not superior to the same dose of rectal indomethacin regarding preventing PEP.

术前使用100毫克直肠双氯芬酸并不比相同剂量的直肠吲哚美辛更有效预防胰胆管造影术后胰腺炎（PEP）。

These findings supported current clinical practice guidelines of 100 mg indomethacin or diclofenac for PEP prophylaxis in patients without contraindications.

这些发现支持了目前的临床实践指南，即在没有禁忌症的患者中，使用100 mg的吲哚美辛或双氯芬酸进行PEP预防。

trial_registration_number

ClinicalTrials.gov (NCT05947461).

ClinicalTrials.gov (NCT05947461).