Esophageal Squamous Cell CarcinomaNCT06192212
PPIO-005 The Relationship Between Different Nutritional Pathways and Tumor Outcomes After Minimally Invasive Esophagectomy
An observational study of Esophageal Squamous Cell Carcinoma, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- How many people
- 577 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Army Medical Center of the People's Liberation Army
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Relationship Between Different Nutritional Modalities and Tumor Prognosis After Minimally Invasive Esophagectomy
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.
Read the detailed 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.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- esophageal squamous cell carcinomas; Jejunostomy; nutrition; postoperative complications; Anastomotic leak
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Postoperative Complications, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Jejunostomy group | Intraoperative jejunostomy tube placement received | |
| Non-jejunostomy group | Intraoperative jejunostomy tube placement not received |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative adverse events
including pneumonia, adult respiratory distress syndrome (ARDS), anastomotic leak (AL), vocal cord paralysis, chylothorax, pneumothorax, pleural effusion, cardiovascular complications
Measured: Within 90 days after surgery
perioperative 90-day mortality.
Measured: Within 90 days
Secondary outcomes (1)
Albumin loss rate
((Preoperative albumin-POD7~10 albumin))⁄(Preoperative albumin) *100%
Measured: 7-10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start13 Dec 2023
- Primary completion25 Dec 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI GUO, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192212
- Sponsor's protocol ID
- WeiGuo
- Status last verified
- Sep 2025
- First submitted
- 21 Dec 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39821455
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Different Nutritional Modalities and Tumor Prognosis After Minimally Invasive Esophagectomy
- ClinicalTrials.gov ID
- NCT06192212
- Acronym / sponsor ID
- WeiGuo
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- esophageal squamous cell carcinomas; Jejunostomy; nutrition; postoperative complications; Anastomotic leak
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jejunostomy group | – | –Intraoperative jejunostomy tube placement received |
| Non-jejunostomy group | – | –Intraoperative jejunostomy tube placement not received |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative adverse events
Time frame: Within 90 days after surgery
including pneumonia, adult respiratory distress syndrome (ARDS), anastomotic leak (AL), vocal cord paralysis, chylothorax, pneumothorax, pleural effusion, cardiovascular complications
perioperative 90-day mortality.
Time frame: Within 90 days
1 secondary outcome
Albumin loss rate
Time frame: 7-10 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 39821455Pu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative adverse events (time frame: Within 90 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06192212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.