Functional Jejunal Interposition Improve Nutritional Status After Total Gastrectomy

NCT01996059 | Unknown Phase 3

• 1 other identifier: 2012017
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out whether the nutritional status of patients undergoing Functional Jejunal Interposition is better than those with Roux-en-Y After Total Gastrectomy for Gastric Cancer. To find a better reconstruction for patients who received total gastrectomy.

Conditions

Gastric Cancer; Nutrition Disorders

Keywords

nutritional status; functional jejunal interposition; Roux-en-Y; gastrectomy

Outcome Measures

Primary Outcomes (1)

• Body Mass Index

  3 months

Secondary Outcomes (1)

• Onodera Prognosis Nutritional Index

  3 months

Other Outcomes (1)

• Visick rates

  3 months

Study Arms (2)

Functional Jejunal Interposition

EXPERIMENTAL

First, an end-to-side esophagojejunostomy was performed at 40 cm anal to Treitz's ligament. Then, an end-to-side duodenojejunostomy was created at the efferent limb 35 cm distal to the esophagojejunostomy, followed by a side-to-side jejunostomy at 5 cm distal to duodenojejunostomy and 20 cm distal to Treitz's ligament. Finally, 2 jejunal proper ligations were made at 5 cm oral to esophagojejunostomy and 2 cm distal to duodenojejunostomy.

Procedure: Functional Jejunal Interposition

Roux-en-Y

ACTIVE COMPARATOR

The distal end of the duodenum was closed. The jejunum was separated 15-20cm distal to the Treitz's ligament, and an end-to-side esophagojejunostomy was done at the distal side of the jejunum. Then, the continuity of the jejunum was reconstructed with side-to-end jejunojejunostomy at 40-45cm distal to esophagojejunostomy.

Procedure: Roux-en-Y

Interventions

Functional Jejunal Interposition PROCEDURE

First, an end-to-side esophagojejunostomy was performed at 40 cm anal to Treitz's ligament. Then, an end-to-side duodenojejunostomy was created at the efferent limb 35 cm distal to the esophagojejunostomy, followed by a side-to-side jejunostomy at 5 cm distal to duodenojejunostomy and 20 cm distal to Treitz's ligament. Finally, 2 jejunal proper ligations were made at 5 cm oral to esophagojejunostomy and 2 cm distal to duodenojejunostomy.

Functional Jejunal Interposition

Roux-en-Y PROCEDURE

The distal end of the duodenum was closed. The jejunum was separated 15-20cm distal to the Treitz's ligament, and an end-to-side esophagojejunostomy was done at the distal side of the jejunum. Then, the continuity of the jejunum was reconstructed with side-to-end jejunojejunostomy at 40-45cm distal to esophagojejunostomy.

Roux-en-Y

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated patients with curative resectable gastric cancer (A)a clear pathological diagnosis (B)the surgeon and radiologist assess the possibility of removal (C)no previous history of other malignancies. (D)the patient has signed an informed consent form (E)cardiopulmonary and kidney function is normal (F)ECOG body condition scores 0 to 1 (G)does not require emergency surgery

You may not qualify if:

• \- (A) pregnant or lactating women; (B) of the liver, lung, bone, and other distant metastasis; (C) positive supraclavicular lymph nodes, pelvic or ovarian species, peritoneal dissemination, etc.; (D) massive ascites, cachexia; (E) with other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poor merger control hypertension, diabetes; (F) mental disorder or disease; (G) 4 weeks prior to enrollment participated or are participating in other clinical trials of patients; (H) had undergone surgery, and its influence has not been eliminated for patients; (I) a history of stomach or esophagus cancer, including stromal tumors, sarcoma, lymphoma, carcinoid; (J) combined with active infection in patients (infection caused by fever above 38 ℃); (K) in patients with poor compliance or poor patient compliance investigators to consider; (L) Some researchers believe that other clinical, laboratory conditions patients should not participate in the trial.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

the 6th Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Nutrition Disorders

Interventions

Anastomosis, Roux-en-Y

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Junsheng Peng, professor

  Department of Gastrointestinal Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaobin Woo, Doctor

CONTACT

+86 20 38254092; xiaobinwoo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 27, 2013
• Study Start: July 1, 2012
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2022
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

CN (1)