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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Relationship Between Different Nutritional Modalities and Tumor Prognosis After Minimally Invasive Esophagectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06192212
• Other study ID #: WeiGuo
• Status: Active, not recruiting
• Start date: December 13, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2024
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Esophageal cancer ranks ninth globally in terms of cancer incidence and sixth in terms of cancer deaths. In addition to the tumor itself and the surgical strike, nutrition and complications are two key factors limiting the rapid recovery of esophagectomy patients. A large number of studies have shown that rational nutritional support will help to improve the nutritional status of postoperative patients and reduce the risk of complications, and compared with parenteral nutrition, enteral nutrition has the advantages of lower complication rate, more economical and safer. Therefore, enteral nutrition is often recommended for esophageal cancer patients in the early postoperative period.

However, the commonly used clinical enteral nutrition includes transoral, nasoenteric tube (NT), gastrostomy and jejunostomy tube (JT) feeding. The optimal method of enteral nutrition after esophageal cancer surgery has been hotly debated in various published articles, but contradictions still exist. There have been numerous studies in recent years on the routine placement of jejunostomy tubes after esophageal cancer surgery, but none of them has yet reached an unanimously accepted conclusion.

Theoretically, a JT reduces the risk of detachment compared with an NT because the catheter is sutured to the abdominal wall; at the same time, a JT is placed deeper than an NT and farther away from the pyloric inlet, thus reducing the incidence of reflux. Most importantly, jejunostomy is considered to be comfortable and effective for long-term nutritional support, and patients can achieve long-term tube feeding at home through the JT, which can satisfy early discharge in case of insufficient oral intake and prevent readmission due to insufficient transoral intake.

Some studies have also confirmed these views, claiming that jejunostomy does not increase the incidence of total complications but improves QOL scores and short-term nutritional indices. It also eliminates the foreign body sensation of nasal mucosal nutritional tubes, and these patients showed acceptable tolerance to catheter insertion. Some researchers have also shown that jejunostomy does not affect the long-term oncological outcomes of patients undergoing esophageal cancer surgery, while increasing the incidence of perioperative complications, with data showing an overall complication rate of 13-38% after jejunostomy, and 0-3% of patients experiencing serious complications that require management, and therefore is not routinely recommended.

In summary, the final conclusion of the current clinical studies on whether to adopt jejunostomy after esophageal cancer resection is still controversial. Meanwhile, to the best of our knowledge, no study has yet examined the circumstances under which the option of performing a jejunostomy may be beneficial to patients. Therefore, in this study, on the basis of analyzing the relationship between the routine placement of jejunostomy tubes and tumor outcomes, and investigating whether jejunostomy brings benefits to patients after esophageal cancer surgery, we propose to conduct subgroup analyses of OS to clarify whether it may bring clear benefits to patients under certain circumstances, so as to guide clinicians to choose to perform this procedure in an appropriate manner.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 577
• Est. completion date: June 1, 2024
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1. 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).

Exclusion Criteria:

• 1. 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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Locations

Country	Name	City	State
China	Army Medical Center of the People's Liberation Army	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	perioperative 90-day mortality.		Within 90 days
Secondary	Albumin loss rate	((Preoperative albumin-POD7~10 albumin))/(Preoperative albumin) *100%	7-10 days after surgery