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| Name | Class |
|---|---|
| Zhejiang Provincial People's Hospital | OTHER |
| Shanghai Cancer Centre | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| People's Hospital of Chongqing |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| routine nasogastric tube | Active Comparator | standard nasogastric tube placement with the tube retained postoperatively |
|
| routine omission of the nasogastric tube | Experimental | avoidance of prophylactic nasogastric tube placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasogastric tube decompression | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junzhe Zhuo | Contact | +86 18250336385 | jz.zhuo@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Min Wang | 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | China |
Deidentified individual participant data (IPD) underlying the results reported in publications, along with the data dictionary, will be made available.
Beginning 6 months after publication of the primary results and ending 5 years thereafter.
Researchers who provide a methodologically sound proposal may request access. Proposals will be reviewed by the study team. Access will be provided after execution of a data use agreement. Data will be accessed via a secure platform or institutional controlled-access repository.
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| OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| The Second Affiliated Hospital of the Army Medical University | UNKNOWN |
| West China Hospital | OTHER |
| Shanxi Province Cancer Hospital | OTHER |
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| Omission of nasogastric tube decompression | Procedure | 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. |
|
| abdominal complications | incidence of abdominal complications: surgical-site infection, intra-abdominal abscess, paralytic ileus, gastric dilatation and gastroenteric anastomotic leak | 30 days postoperatively |
| pulmonary complications | incidence of pulmonary complications, including pneumonia, pulmonary embolism, atelectasis and pleural effusion | 30 days postoperatively |
| comfort | nasogastric-tube-related discomfort scores (10-cm visual analogue scale) | 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 | Up to 90 days postoperatively |
| Hospitalization cost | Total hospitalization costs | 90 days postoperatively |
| Mortality rate | all-cause mortality rate at postoperative 90 days | 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. | 90 days postoperatively |
| Length of stay | Days from the date of surgery to the date of discharge | Up to 90 days postoperatively |