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Prospective study on the usefulness of K-2S plus as as enteral nutrients after pancreatoduodenectomy

Prospective study on the usefulness of K-2S plus as as enteral nutrients after pancreatoduodenectomy - Prospective study on the usefulness of K-2S plus as as enteral nutrients after pancreatoduodenectomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036511
Enrollment
40
Registered
2019-05-07
Start date
2019-05-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who undergo pancreatoduodenectomy for peri-pancreatic tumors such as pancreatic cancers or lower bile duct cancers

Interventions

Patients who will undergo PD will be prospectively registered and assigned to K-2S plus group from patients who have started registration. When the number of cases in the K-2S plus group reaches 20, t

Sponsors

Kumamoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Cases where the age of registration date is over 20 years old (2) PS (ECOG) 0 or 1 case (3) Cases that meet all the following conditions For all test items, the latest value is used within 14 days before surgery (a test on the same day two weeks before the registration date is acceptable). 1) White blood cells> or more 4,000 and < or less 12,000. 2) Neutrophil> or more 2,000. 3) Platelets> or more 100,000. 4) Hemoglobin> or more 8.0. 5) AST< or less 100. 6) ALT< or less 100. 7) Total bilirubin< or less 1.2. 8) Serum creatinine< or less 1.2. (4) Cases that can be taken orally (Dysphagia score< or less 1).

Exclusion criteria

Exclusion criteria: (1) Patients who are contraindicated with K-2S plus or Erental 1) A case with allergies to eggs, dairy products and soy 2) A case with hypersensitivity to K-2S plus 3) A case with hypersensitivity to Ellenthal 4) A case with amino acid metabolism disorder (2) Cases with active bacterial and fungal infections (cases with fever above 38 degree and cases where bacterial infection has been shown by imaging or bacteriological examination). (3) A case that is complicated by psychosis or psychiatric symptoms and difficult to participate in this study. (4) Cases that the study responsible (share) physician judged inappropriate for this study

Design outcomes

Primary

MeasureTime frame
Defecation frequency Fecal condition (Bristol scale)

Secondary

MeasureTime frame
Weight loss rate Lymphocyte count and reduction rate Serum albumin level and reduction rate Serum prealbumin (transthyretin) levels and reduction rates Postoperative complication rate (Clavian-Dindo IIIa or more) Enteral nutrition protocol completion rate Enteral nutrition protocol total administered calories Total calories required after enteral feeding protocol

Countries

Japan

Contacts

Public ContactYo-ichi Yamashita

Graduate School of Medical Sciences, Kumamoto University Department of Gastroenterological Surgery

y-yama@kumamoto-u.ac.jp096-373-5211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026