PPIO-005 The Relationship Between Different Nutritional Pathways and Tumor Outcomes After Minimally Invasive Esophagectomy

NCT06192212 | Completed

• 1 other identifier: WeiGuo
• Study Type: observational
• Target: 577
• Locations: 1 country
• Sites: 1

Brief Summary

As there is no consensus to date on the optimal postoperative nutritional support route for patients undergoing minimally invasive esophagectomy, the purpose of this study is to assess whether there is a potential advantage to receiving jejunostomy feedings for postoperative patients undergoing McKeown MIE as compared to the conventional nasoenteric tube feeding method.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

esophageal squamous cell carcinomas; Jejunostomy; nutrition; postoperative complications; Anastomotic leak

Outcome Measures

Primary Outcomes (2)

• postoperative adverse events

  including pneumonia, adult respiratory distress syndrome (ARDS), anastomotic leak (AL), vocal cord paralysis, chylothorax, pneumothorax, pleural effusion, cardiovascular complications

  Within 90 days after surgery

• perioperative 90-day mortality.

  Within 90 days

Secondary Outcomes (1)

• Albumin loss rate

  7-10 days after surgery

Study Arms (2)

Jejunostomy group

Intraoperative jejunostomy tube placement received

Non-jejunostomy group

Intraoperative jejunostomy tube placement not received

Eligibility Criteria

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

Study Population

patients with EC who attended the Department of Thoracic Surgery at Daping Hospital and underwent the McKeown MIE procedure performed by the same surgical team were included for evaluation from September, 2017, to September, 2021.

You may qualify if:

• \. Patients with a clear pathologic diagnosis of esophageal squamous cell carcinoma; 2. Received minimally invasive McKeown procedure; 3. Patients with R0 resection (R0: radical resection).

You may not qualify if:

• \. Biopsy pathologic diagnosis of other types of esophageal cancer, e.g., adenocarcinoma; 2. Simultaneous combination of other primary cancers or history of other cancers; 3. Received minimally invasive Ivor-Lewis procedure or Sweet procedure; 4. Patients with R1 or R2 resection (R1 resection: microscopic tumor residue; R2: naked eye tumor residue); 5. Preoperative distant metastases; 6. Preoperative serious comorbidities in other systems; 7. Incomplete medical record data.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Army Medical Center of the People's Liberation Army

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (1)

• Pu XS, Bao T, Wang YJ, Li KK, Yang Q, He XD, He Y, Yu J, Xie XF, Chen X, Guo W. Laparoscopic jejunostomy during McKeown minimally invasive esophagectomy: a propensity score analysis. Surg Endosc. 2025 Mar;39(3):1801-1810. doi: 10.1007/s00464-024-11519-x. Epub 2025 Jan 17.

  PMID: 39821455 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Postoperative Complications; Anastomotic Leak

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: December 13, 2023
• Primary Completion: December 25, 2023
• Study Completion: June 1, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)