Early enteral vs. oral nutrition after Whipple procedure: Study protocol for a multicentric randomized controlled trial (NUTRIWHI trial)

Joliat, Gaëtan‐Romain; Martín, David; Labgaa, Ismaïl; Melloul, Emmanuel; Uldry, Émilie; Halkic, Nermin; Fotsing, Ginette; Cristaudi, Alessandra; Majno‐Hurst, Pietro; Vrochides, Dionisios; Demartines, Nicolas; Schäfer, Markus

doi:10.3389/fonc.2022.855784

Cited by 2 publications

(2 citation statements)

References 40 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In 2022, Joliat et al ( 29 ) published the protocol of a multicenter, open-label, RCT for patients undergoing PD with a nutritional risk screening ≥3 in a setting of full ERAS strategy. Patients will be randomized to receive either early enteral nutrition (intervention group) or oral nutrition (control group) after the operation.…”

Section: Discussionmentioning

confidence: 99%

ERAS with or without supplemental artificial nutrition in open pancreatoduodenectomy for cancer. A multicenter, randomized, open labeled trial (RASTA study protocol)

et al. 2023

View full text Add to dashboard Cite

PurposeThe role of supplemental artificial nutrition in patients perioperatively treated according to enhanced recovery programs (ERAS) on surgery-related morbidity is not known. Therefore, there is a need of a clinical trials specifically designed to explore whether given a full nutritional requirement by parenteral feeding after surgery coupled with oral food “at will” compared to oral food “at will” alone, within an established ERAS program, could achieve a reduction of the morbidity burden.Materials and analysisRASTA will be a multicenter, randomized, parallel-arm, open labeled, superiority trial. The trial will be conducted in five Italian Institutions with proven experience in pancreatic surgery and already applying an established ERAS program. Adult patients (age ≥ 18 and < 90 years of age) candidate to elective open pancreatoduodenectomy (PD) for any periampullary or pancreatic cancer will be randomized to receive a full ERAS protocol that establishes oral food “at will” plus parenteral nutrition (PN) from postoperative day 1 to day 5 (treatment arm), or to ERAS protocol without PN (control arm). The primary endpoint of the trial is the complication burden within 90 days after the day of surgery. The complication burden will be assessed by the Comprehensive Complication Index, that incorporates all complications and their severity as defined by the Clavien-Dindo classification, and summarizes postoperative morbidity with a numerical scale ranging from 0 to 100. The H0 hypothesis tested is that he administration of a parenteral nutrition added to the ERAS protocol will not affect the CCI as compared to standard of care (ERAS). The H1 hypothesis is that the administration of a parenteral nutrition added to the ERAS protocol will positively affect the CCI as compared to standard of care (ERAS). The trial has been registered at ClinicalTrials.gov (number: NCT04438447; date: 18/05/2020).ConclusionThis upcoming trial will permit to establish if early postoperative artificial nutritional support after PD may improve postoperative outcomes compared to oral nutrition alone within an established ERAS program.

show abstract

Section: Discussionmentioning

confidence: 99%

ERAS with or without supplemental artificial nutrition in open pancreatoduodenectomy for cancer. A multicenter, randomized, open labeled trial (RASTA study protocol)

et al. 2023

View full text Add to dashboard Cite

show abstract

“… 107 In addition, the NUTRIWHI trial in the United States aiming to recruit 128 participants (including CP patients) is ongoing to assess the impact of enteral and oral nutrition on the clinical outcomes of patients who undergo Whipple surgery (NCT05042882). 108 …”

Section: Surgical Strategymentioning

confidence: 99%

Management of chronic pancreatitis: recent advances and future prospects

Han,

Lv,

2024

Therap Adv Gastroenterol

View full text Add to dashboard Cite

As a progressive fibroinflammatory disease, chronic pancreatitis (CP) often manifests as recurrent bouts of abdominal pain with or without complications, causing a heavy burden of health care. In recent years, some meaningful insights into the management of CP have been obtained from randomized controlled trials, systematic reviews, and meta-analyses, which were of great importance. Based on this research, it is shown that there are various treatments for CP. Therefore, it is of great importance to choose a suitable strategy for patients with CP individually. Relevant evidence on the management of CP was summarized in this review, including nutrition supplements, medication, endoscopy, surgery, exploration of novel therapies as well as evaluation and prediction of treatment response.

show abstract

Early enteral vs. oral nutrition after Whipple procedure: Study protocol for a multicentric randomized controlled trial (NUTRIWHI trial)

Cited by 2 publications

References 40 publications

ERAS with or without supplemental artificial nutrition in open pancreatoduodenectomy for cancer. A multicenter, randomized, open labeled trial (RASTA study protocol)

ERAS with or without supplemental artificial nutrition in open pancreatoduodenectomy for cancer. A multicenter, randomized, open labeled trial (RASTA study protocol)

Management of chronic pancreatitis: recent advances and future prospects

Contact Info

Product

Resources

About