PancreaticoduodenectomyPhase 2NCT07370116
Omitting Nasogastric Tube Decompression in Minimally Invasive Pancreaticoduodenectomy
A Phase 2 study testing nasogastric tube decompression and Omission of nasogastric tube decompression in people with Pancreaticoduodenectomy and Nasogastric Tube Decompression, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study will evaluate two perioperative nasogastric tube strategies in patients undergoing laparoscopic pancreatoduodenectomy. The goal is to determine whether routine omission of a nasogastric tube is not worse than routine nasogastric tube placement in terms of overall complications and postoperative recovery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreaticoduodenectomy, Nasogastric Tube Decompression, Minimally Invasive Surgical Procedures
- What is being tested?
- nasogastric tube decompression and Omission of nasogastric tube decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 years and 75 years.
- Indication for MIPD confirmed by MDT evaluation.
- Ability to understand trial requirements and willingness to adhere to study protocols.
- Written informed consent obtained before registration.
- Curative-intent treatment consistent with international clinical guidelines.
Who cannot join
- Requirement of partial or total pancreatectomy or other palliative procedures, or presence of distant metastases (peritoneal, hepatic, distant nodal, or other organ involvement); therefore, these patients are not candidates for MIPD.
- American Society of Anaesthesiologists (ASA) Physical Status ≥ IV.
- Pregnant or breastfeeding women.
- Severe psychiatric disorders.
- History of other malignancy.
- Neoadjuvant chemoradiotherapy prior to surgery.
Show all 11Show fewer
- Body mass index >35 kg/m2.
- History of nasopharyngeal, gastric or oesophageal surgery.
- Preoperative gastrointestinal obstruction.
- Contraindications to nasogastric intubation, including recent caustic ingestion, oesophageal stricture/diverticulum, or maxillofacial trauma.
- Participation in any other clinical trials within 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
About this study
Official title: Safety and Feasibility of Omitting Nasogastric Decompression in Minimally Invasive Pancreaticoduodenectomy: a Multicenter Non-inferiority Randomized Controlled Trial
This study will evaluate two perioperative nasogastric tube strategies in patients undergoing laparoscopic pancreatoduodenectomy. The goal is to determine whether routine omission of a nasogastric tube is not worse than routine nasogastric tube placement in terms of overall complications and postoperative recovery.
Participants will be randomly assigned to one of two groups. Each group will receive the assigned nasogastric tube strategy during and after surgery, and will be followed during the hospital stay and after discharge for up to postoperative 90 days. Information will be collected from routine clinical care, including discomfort score, symptoms, imaging or laboratory tests when clinically indicated, and postoperative outcomes.
The main outcome of this study is the overall burden of postoperative complications within 30 days after surgery, measured using the Comprehensive Complication Index, which summarizes all complications into a single score. Secondary outcomes include rates of pancreas surgery-specific complications (such as delayed gastric emptying, pancreatic fistula, bile leak, bleeding, and chyle leak), other abdominal and pulmonary complications, and organ dysfunction (including kidney injury, sepsis, and new cardiac dysfunction). The study will also evaluate patient discomfort related to the nasogastric tube (pain/discomfort scores), the need for nasogastric tube reinsertion, postoperative recovery milestones (ability to resume oral intake and length of hospital stay), healthcare costs, and all-cause mortality at 30 and 90 days after surgery.
- Conditions
- Pancreaticoduodenectomy, Nasogastric Tube Decompression, Minimally Invasive Surgical Procedures
- Being tested
- nasogastric tube decompression, Omission of nasogastric tube decompression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasogastric tube decompressionProcedure or surgery
Nasogastric tube decompression means standard NGT placement with the tube retained postoperatively until the drainage volume is <500 ml/day on postoperative day 3. Nasogastric tube placement will adhere to the following requirements: pre-insertion nasal patency assessment excluding the side with septal deviation or polyps, catheter pre-measurement from the apex nasi to the ear lobe and xiphoid process, and lubrication with liquid paraffin. After advancement into the pharynx, conscious patients will undergo repeated swallowing to facilitate passage, whereas unconscious patients will require laryngeal elevation with neck flexion to prevent tracheal intubation.
Omission of nasogastric tube decompressionProcedure or surgery
Omission of nasogastric tube decompression means avoidance of prophylactic NGT placement throughout the perioperative period. If intraoperative NGT insertion becomes necessary because of acute gastric dilatation, the tube should be removed before anesthesia emergence.
| Study group | Role | What they receive |
|---|---|---|
| routine nasogastric tube | Active comparator | standard nasogastric tube placement with the tube retained postoperatively Receives: Procedure: nasogastric tube decompression |
| routine omission of the nasogastric tube | Experimental | avoidance of prophylactic nasogastric tube placement Receives: Procedure: Omission of nasogastric tube decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Complication Index
Comprehensive Complication Index calculates a weighted sum of complications graded by the Clavien-Dindo classification that occur within 30 days postoperatively to generate a continuous score from 0 (no complications) to 100 (death), quantifying the overall postoperative complication burden
Measured: 30 days postoperatively
Secondary outcomes (9)
pancreaticoduodenectomy-specific complications
incidence of pancreaticoduodenectomy-specific complications, defined and classified according to International Study Group of Pancreatic Surgery criteria: delayed gastric emptying, postoperative pancreatic fistula, postoperative bile leak, postpancreatectomy haemorrhage, chyle leak and major complications (Clavien-Dindo grade ≥ II)
Measured: 30 days postoperatively
abdominal complications
incidence of abdominal complications: surgical-site infection, intra-abdominal abscess, paralytic ileus, gastric dilatation and gastroenteric anastomotic leak
Measured: 30 days postoperatively
pulmonary complications
incidence of pulmonary complications, including pneumonia, pulmonary embolism, atelectasis and pleural effusion
Measured: 30 days postoperatively
comfort
nasogastric-tube-related discomfort scores (10-cm visual analogue scale)
Measured: 30 days postoperatively
Time to tolerate oral intake (liquids/solids)
Time from the end of surgery to the first time the participant begins and tolerates liquid (and separately solid) oral intake
Measured: Up to 90 days postoperatively
Hospitalization cost
Total hospitalization costs
Measured: 90 days postoperatively
Mortality rate
all-cause mortality rate at postoperative 90 days
Measured: 90 days posoperatively
Rescue nasogastric tube insertion
Postoperative placement (or reinsertion) of a nasogastric tube due to persistent distension, nausea, or vomiting, or if imaging was suggestive of gastrointestinal obstruction.
Measured: 90 days postoperatively
Length of stay
Days from the date of surgery to the date of discharge
Measured: Up to 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, Shanghai Cancer Centre, The Second Hospital of Hebei Medical University, People's Hospital of Chongqing, Shanghai Zhongshan Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Shandong Provincial Hospital, Second Affiliated Hospital of Army Medical University, West China Hospital, Shanxi Province Cancer Hospital
- Responsible party
- Principal investigator, Min Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Min Wang, Principal investigator, Department of Pancreatic and Gastric Surgery, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370116
- Sponsor's protocol ID
- NCC2025C1365
- Status last verified
- Mar 2026
- First submitted
- 2 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) underlying the results reported in publications, along with the data dictionary, will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Omitting Nasogastric Decompression in Minimally Invasive Pancreaticoduodenectomy: a Multicenter Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07370116
- Acronym / sponsor ID
- NCC2025C1365
- Conditions
- Pancreaticoduodenectomy, Nasogastric Tube Decompression, Minimally Invasive Surgical Procedures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, Shanghai Cancer Centre, The Second Hospital of Hebei Medical University, People's Hospital of Chongqing, Shanghai Zhongshan Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Shandong Provincial Hospital, Second Affiliated Hospital of Army Medical University, West China Hospital, Shanxi Province Cancer Hospital
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 27 Jan 2026 (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 will evaluate two perioperative nasogastric tube strategies in patients undergoing laparoscopic pancreatoduodenectomy. The goal is to determine whether routine omission of a nasogastric tube is not worse than routine nasogastric tube placement in terms of overall complications and postoperative recovery.
Participants will be randomly assigned to one of two groups. Each group will receive the assigned nasogastric tube strategy during and after surgery, and will be followed during the hospital stay and after discharge for up to postoperative 90 days. Information will be collected from routine clinical care, including discomfort score, symptoms, imaging or laboratory tests when clinically indicated, and postoperative outcomes.
The main outcome of this study is the overall burden of postoperative complications within 30 days after surgery, measured using the Comprehensive Complication Index, which summarizes all complications into a single score. Secondary outcomes include rates of pancreas surgery-specific complications (such as delayed gastric emptying, pancreatic fistula, bile leak, bleeding, and chyle leak), other abdominal and pulmonary complications, and organ dysfunction (including kidney injury, sepsis, and new cardiac dysfunction). The study will also evaluate patient discomfort related to the nasogastric tube (pain/discomfort scores), the need for nasogastric tube reinsertion, postoperative recovery milestones (ability to resume oral intake and length of hospital stay), healthcare costs, and all-cause mortality at 30 and 90 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine nasogastric tube | Active comparator | Procedure: nasogastric tube decompressionstandard nasogastric tube placement with the tube retained postoperatively |
| routine omission of the nasogastric tube | Experimental | Procedure: Omission of nasogastric tube decompressionavoidance of prophylactic nasogastric tube placement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 years and 75 years.
- Indication for MIPD confirmed by MDT evaluation.
- Ability to understand trial requirements and willingness to adhere to study protocols.
- Written informed consent obtained before registration.
- Curative-intent treatment consistent with international clinical guidelines.
Key exclusion criteria (11 listed)
- Requirement of partial or total pancreatectomy or other palliative procedures, or presence of distant metastases (peritoneal, hepatic, distant nodal, or other organ involvement); therefore, these patients are not candidates for MIPD.
- American Society of Anaesthesiologists (ASA) Physical Status ≥ IV.
- Pregnant or breastfeeding women.
- Severe psychiatric disorders.
- History of other malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasogastric tube decompressionNasogastric tube decompression means standard NGT placement with the tube retained postoperatively until the drainage volume is <500 ml/day on postoperative day 3. Nasogastric tube placement will adhere to the following requirements: pre-insertion nasal patency assessment excluding the side with septal deviation or polyps, catheter pre-measurement from the apex nasi to the ear lobe and xiphoid process, and lubrication with liquid paraffin. After advancement into the pharynx, conscious patients will undergo repeated swallowing to facilitate passage, whereas unconscious patients will require laryngeal elevation with neck flexion to prevent tracheal intubation. | Procedure or surgery | routine nasogastric tube |
| Omission of nasogastric tube decompressionOmission of nasogastric tube decompression means avoidance of prophylactic NGT placement throughout the perioperative period. If intraoperative NGT insertion becomes necessary because of acute gastric dilatation, the tube should be removed before anesthesia emergence. | Procedure or surgery | routine omission of the nasogastric tube |
Primary outcome
Comprehensive Complication Index
Time frame: 30 days postoperatively
Comprehensive Complication Index calculates a weighted sum of complications graded by the Clavien-Dindo classification that occur within 30 days postoperatively to generate a continuous score from 0 (no complications) to 100 (death), quantifying the overall postoperative complication burden
9 secondary outcomes
pancreaticoduodenectomy-specific complications
Time frame: 30 days postoperatively
abdominal complications
Time frame: 30 days postoperatively
pulmonary complications
Time frame: 30 days postoperatively
comfort
Time frame: 30 days postoperatively
Time to tolerate oral intake (liquids/solids)
Time frame: Up to 90 days postoperatively
Hospitalization cost
Time frame: 90 days postoperatively
Mortality rate
Time frame: 90 days posoperatively
Rescue nasogastric tube insertion
Time frame: 90 days postoperatively
Length of stay
Time frame: Up to 90 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) underlying the results reported in publications, along with the data dictionary, will be made available.
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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.
Min Wang principal investigator
Department of Pancreatic and Gastric Surgery, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nasogastric tube decompression and Omission of nasogastric tube decompression in people with Pancreaticoduodenectomy and Nasogastric Tube Decompression, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 12 Mar 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junzhe Zhuo (+86 18250336385, jz.zhuo@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication Index (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.