Minimally Invasive Surgical Procedures, Nasogastric Tube Decompression, Pancreaticoduodenectomy
Conditions
Brief 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. 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.
Interventions
PROCEDUREnasogastric tube decompression
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.
PROCEDUREOmission of nasogastric tube decompression
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.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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
The Second Affiliated Hospital of the Army Medical University
West China Hospital
Shanxi Province Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 years and 75 years. 2. Indication for MIPD confirmed by MDT evaluation. 3. Ability to understand trial requirements and willingness to adhere to study protocols. 4. Written informed consent obtained before registration. 5. Curative-intent treatment consistent with international clinical guidelines.
Exclusion criteria
1. 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. 2. American Society of Anaesthesiologists (ASA) Physical Status ≥ IV. 3. Pregnant or breastfeeding women. 4. Severe psychiatric disorders. 5. History of other malignancy. 6. Neoadjuvant chemoradiotherapy prior to surgery. 7. Body mass index \>35 kg/m2. 8. History of nasopharyngeal, gastric or oesophageal surgery. 9. Preoperative gastrointestinal obstruction. 10. Contraindications to nasogastric intubation, including recent caustic ingestion, oesophageal stricture/diverticulum, or maxillofacial trauma. 11. Participation in any other clinical trials within 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive Complication Index | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comfort | 30 days postoperatively | nasogastric-tube-related discomfort scores (10-cm visual analogue scale) |
| pancreaticoduodenectomy-specific complications | 30 days postoperatively | 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) |
| abdominal complications | 30 days postoperatively | incidence of abdominal complications: surgical-site infection, intra-abdominal abscess, paralytic ileus, gastric dilatation and gastroenteric anastomotic leak |
| Time to tolerate oral intake (liquids/solids) | Up to 90 days postoperatively | Time from the end of surgery to the first time the participant begins and tolerates liquid (and separately solid) oral intake |
| Hospitalization cost | 90 days postoperatively | Total hospitalization costs |
| Mortality rate | 90 days posoperatively | all-cause mortality rate at postoperative 90 days |
| Rescue nasogastric tube insertion | 90 days postoperatively | Postoperative placement (or reinsertion) of a nasogastric tube due to persistent distension, nausea, or vomiting, or if imaging was suggestive of gastrointestinal obstruction. |
| pulmonary complications | 30 days postoperatively | incidence of pulmonary complications, including pneumonia, pulmonary embolism, atelectasis and pleural effusion |
| Length of stay | Up to 90 days postoperatively | Days from the date of surgery to the date of discharge |
Countries
China
Contacts
CONTACTJunzhe Zhuo
PRINCIPAL_INVESTIGATORMin 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
Outcome results
None listed