PancreatoduodenectomyNCT05573399
Early Oral Feeding for Patients After Pancreaticoduodenectomy
An observational study of Pancreatoduodenectomy, run by Changhai Hospital at 1 site in China.
Trial summary
This study intends to retrospectively analyze the patients who underwent pancreatoduodenectomy and compare the safety and feasibility between early enteral nutrition through nasojejunal tube and early oral feeding after pancreatoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatoduodenectomy
- Type of treatment
- Pill or oral medicine
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 31 Dec 2021
- 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 who underwent pancreaticoduodenectomy in Changhai Hospital.
Who may be able to join
- Patients who underwent pancreaticoduodenectomy by a certain surgeon in Changhai Hospital
- Patients who were treated with nasojejunal enteral nutrition or oral enteral nutrition after operation.
Who cannot join
- Patients who underwent pancreaticoduodenectomy by other surgeons during the same period;
- Patients who received other nutritional support rather than nasojejunal tube enteral nutrition or oral enteral nutrition after operation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy Analysis on Early Oral Feeding Versus Nasojejunal Early Enteral Nutrition for Patients After Pancreaticoduodenectomy
This study intends to retrospectively analyze the patients who underwent pancreatoduodenectomy and compare the safety and feasibility between early enteral nutrition through nasojejunal tube and early oral feeding after pancreatoduodenectomy. This study is expected to revise the guidelines for early nutritional support after pancreaticoduodenectomy, reduce postoperative complications, and provide better guidance for clinical work.
Read the detailed description
Pancreaticoduodenectomy is the standard treatment for periampullary and pancreatic head carcinomas, with the high incidence of perioperative complications ranging from 40% to 60%. Malnutrition is a relevant predictor of post-operative morbidity and mortality after pancreatic surgery. Adequate nutrition is the key to reduce perioperative complications, including abdominal infection, poor healing of wounds, and even gastrointestinal anastomotic leak. The optimal nutritional support method after Pancreaticoduodenectomy is still uncertain, and the current nutritional support methods are diverse. The results of an international survey showed that there was very poor or no agreement on postoperative strategies for the management of nutrition after Pancreaticoduodenectomy. Therefore, the investigators designed this retrospective study to evaluate which was safer and more feasible between early oral feeding and nasojejunal early enteral nutrition after Pancreaticoduodenectomy, using the method of propensity score weighting.
- Conditions
- Pancreatoduodenectomy
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 |
|---|---|---|
| Early oral feeding | No enteral feeding tube was placed after pancreaticoduodenectomy and oral nutrition was given early. Patients were given liquid drinks on the second day after pancreaticoduodenectomy, and solid food from the fifth day. | |
| Early nasojejunal enteral nutrition | Early enteral nutrition was given early through nasojejunal tube. 5% glucose saline was given on the first day after pancreaticoduodenectomy through nasojejunal tube. Enteral nutrition was given from the second day after pancreaticoduodenectomy. When oral intake was adequate, the nasojejunal tube was removed on the sixth day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative complications
Complications defined by ISGPS in perioperative period
Measured: From Operation date to three months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Aug 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
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 PancreatoduodenectomyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo ShiWei, Changhai Hospital
- Investigators
- Gang Jin, Doctor, Principal investigator, Changhai Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573399
- Sponsor's protocol ID
- ChanghaiH-PP11
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jing W, Wu S, Gao S, Shi X, Liu W, Ren Y, Ouyang L, Zheng K, Guo S, Wu C, Jin G. Early oral feeding versus nasojejunal early enteral nutrition in patients following pancreaticoduodenectomy: a propensity score-weighted analysis of 428 consecutive patients. Int J Surg. 2024 Jan 1;110(1):229-237. doi: 10.1097/JS9.0000000000000786.
PubMed 37755371
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy Analysis on Early Oral Feeding Versus Nasojejunal Early Enteral Nutrition for Patients After Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT05573399
- Acronym / sponsor ID
- ChanghaiH-PP11
- Conditions
- Pancreatoduodenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Oct 2022 (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.
This study intends to retrospectively analyze the patients who underwent pancreatoduodenectomy and compare the safety and feasibility between early enteral nutrition through nasojejunal tube and early oral feeding after pancreatoduodenectomy. This study is expected to revise the guidelines for early nutritional support after pancreaticoduodenectomy, reduce postoperative complications, and provide better guidance for clinical work.
Detailed description
Pancreaticoduodenectomy is the standard treatment for periampullary and pancreatic head carcinomas, with the high incidence of perioperative complications ranging from 40% to 60%. Malnutrition is a relevant predictor of post-operative morbidity and mortality after pancreatic surgery. Adequate nutrition is the key to reduce perioperative complications, including abdominal infection, poor healing of wounds, and even gastrointestinal anastomotic leak. The optimal nutritional support method after Pancreaticoduodenectomy is still uncertain, and the current nutritional support methods are diverse. The results of an international survey showed that there was very poor or no agreement on postoperative strategies for the management of nutrition after Pancreaticoduodenectomy. Therefore, the investigators designed this retrospective study to evaluate which was safer and more feasible between early oral feeding and nasojejunal early enteral nutrition after Pancreaticoduodenectomy, using the method of propensity score weighting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early oral feeding | – | –No enteral feeding tube was placed after pancreaticoduodenectomy and oral nutrition was given early. Patients were given liquid drinks on the second day after pancreaticoduodenectomy, and solid food from the fifth day. |
| Early nasojejunal enteral nutrition | – | –Early enteral nutrition was given early through nasojejunal tube. 5% glucose saline was given on the first day after pancreaticoduodenectomy through nasojejunal tube. Enteral nutrition was given from the second day after pancreaticoduodenectomy. When oral intake was adequate, the nasojejunal tube was removed on the sixth day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent pancreaticoduodenectomy in Changhai Hospital.
Key inclusion criteria (2 listed)
- Patients who underwent pancreaticoduodenectomy by a certain surgeon in Changhai Hospital
- Patients who were treated with nasojejunal enteral nutrition or oral enteral nutrition after operation.
Key exclusion criteria (2 listed)
- Patients who underwent pancreaticoduodenectomy by other surgeons during the same period;
- Patients who received other nutritional support rather than nasojejunal tube enteral nutrition or oral enteral nutrition after operation.
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
Perioperative complications
Time frame: From Operation date to three months after operation
Complications defined by ISGPS in perioperative period
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 18 Oct 2022.
- Derived from this study: PubMed 37755371Jing W, Wu S, Gao S, Shi X, Liu W, Ren Y, Ouyang L, Zheng K, Guo S, Wu C, Jin G. Early oral feeding versus nasojejunal early enteral nutrition in patients following pancreaticoduodenectomy: a propensity score-weighted analysis of 428 consecutive patients. Int J Surg. 2024 Jan 1;110(1):229-237. doi: 10.1097/JS9.0000000000000786.
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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.
Gang Jin, Doctor principal investigator
Changhai Hospital, Shanghai, China
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 Pancreatoduodenectomy, run by Changhai Hospital 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 2 inclusion and 2 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 18 Oct 2022. 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?
Perioperative complications (time frame: From Operation date to three months after operation). 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 NCT05573399, 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 18 Oct 2022.