An Open-Label Prospective Randomized clicical trial to evaluate the Effect of Early Jellied Elemental Diet after Laparoscopically assisted Distal Gastrectomy

An Open-Label Prospective Randomized clicical trial to evaluate the Effect of Early Jellied Elemental Diet after Laparoscopically assisted Distal Gastrectomy - Early Jellied Elemental Diet after Laparoscopically assisted Distal Gastrectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005082

Enrollment

Registered

2011-04-01

Start date

2012-11-01

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

Gastric cancer

Interventions

Patients allocated to trial group take jellied elemental diet (ELENTAL) with/without attached &quot

flavor mix&quot

one pack a day from the 2nd post-operative day to the 7th day. All the patients including trial group take conventional post-operative meals from the 3rd post-operative day. All the patients includin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) A gastric cancer patient diagnosed as clinical stage 1A-2B (Japanese Classification of Gastric Carcinoma The 14th Edition). 2) Planned to receive laparoscopically assisted distal gastrectomy. 3) Planned reconstruction: Gastro-duodenostomy after Billroth 1 or Gastro-jejunostomy after Roux en Y. 4) ECOG Performance Status Scale: 0-1. 5) Greater than or equal to 20 years of age and less than or equal to 80 years of age. 6) Meets the above-mentioned conditions and be able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1) Neo-adjuvant chemotherapy within four weeks prior to the operation. 2) Coexistence/past history of any inflammatory bowel disease; ulcerative colitis or Crohn's disease. 3) Emergency operation. 4) Double cancer. 5) Combined resection of adjacent intestinal tract 6)Dysfunction of major organs. 7) History of allergic reaction to the components of ELENTAL. 8) Suspect of glucose metabolism disorder with severe diabetes mellitus and/or massive administration of corticosteroids 9) During pregnancy and lactation 10) Aminoacidopathy 11) Swallowing disorder 12) Any other condition that, in the investigator's opinion, places the subject at undue risk by participating in the study.

Design outcomes

Primary

Measure	Time frame
Shortening of duration of the first defecation after extubation of endotracheal tube	—

Secondary

Measure	Time frame
Advantages in Blood test: albumin, pre-albumin, retinol-binding protein, total cholesterol, Zn, Cu Advantages in Body composition test by InBody S20TM: Body weight, Body mass index, AMC (arm muscle circumference), TSF (triceps skinfolds)	—

Countries

Japan

Contacts

Public ContactNaoki Tanaka

Tohoku University Hospital Division of Gastrointestinal Surgery

022-717-7205

Outcome results

None listed

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