Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis: A Randomized Controlled Pilot Study
Phase: NA
Conditions: Walled Off Pancreatic Necrosis, Acute Pancreatitis (AP), Endoscopic Ultrasound-Guided Drainage
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

 
 
 

THESIS PROTOCOL 
 
NASOJEJUNAL FEEDING VS. ORAL FEEDING FOLLOWING 
ENDOSCOPIC DRAINAGE OF WALLED OFF PANCREATIC NECROSIS: A 
RANDOMIZED CONTROLLED PILOT STUDY 
 
 
 
 
 
PROTOCOL 
 
 
Submitted in partial fulfilment of the requirement for the degree of DM 
(Gastroenterology) 
Post Graduate Institute of Medical Education and Research, 
Chandigarh, India 
 
                                                                  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
June 2025                                                                                Dr SAURABH KUMAR SINGH 

 
 
CHIEF GUIDE 
 
DR. SURINDER SINGH RANA 
Professor 
Department of Gastroenterology 
PGIMER, Chandigarh 
CO-GUIDES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                Dr. Rajesh Gupta 
Professor & Head, 
Department of GI Surgery, HPB, Liver 
Transplantation 
        Dr. Vikas Gautam 
              Professor 
Department of Microbiology 
PGIMER, Chandigarh 
Dr. Mandeep Kang 
Professor 
Department of Radiodiagnosis 
PGIMER, Chandigarh 
Dr. Nancy Sahni 
Head 
Department of Dietetics 
PGIMER, Chandigarh 
Dr.  Jimil Shah 
Associate Professor 
Department of Gastroenterology 
PGIMER, Chandigarh 
Dr. Vaneet Jearth 
Assistant  Professor 
Department of Gastroenterology 
PGIMER, Chandigarh 
Dr. Kamal Kishore 
Associate Professor 
Department of Biostatistics 
PGIMER, Chandigarh 
Dr. Pankaj Gupta 
Associate  Professor 
Department of Radiodiagnosis 
PGIMER, Chandigarh 

 
Introduction: 
 
Acute pancreatitis is one of most common acute gastrointestinal diseases requiring hospital 
admissions [1]. Acute pancreatitis is an inflammatory process which causes systemic and local 
inflammation. The spectrum of acute pancreatitis can range from interstitial pancreatitis (AIP) 
to necrotizing pancreatitis (ANP). AIP usually have a milder course but around 20% of patients 
develop ANP in whom there is an increased incidence of early organ failure (38%), need for 
intervention (38%) and death (15%) [2]. 
In ANP, necrosis most commonly involves both the pancreatic parenchyma and the 
peripancreatic tissues (75–80% of cases). In about 20% of patients, necrosis is limited to the 
peripancreatic tissues alone, while isolated pancreatic parenchymal necrosis without 
peripancreatic involvement is relatively rare, occurring in less than 5% of cases [3]. 
Revised Atlanta symposium best classifies the local complications of acute pancreatitis (AP)  
Walled off necrosis (WON) usually develops 4 weeks following ANP.WON contains 
encapsulated partially liquified (peri)pancreatic necrotic tissue [4]. 
Most of the acute (peri)pancreatic fluid collections (PFC) resolve spontaneously with 
conservative management [5]. However, about 25% of patients with acute necrotic collections 
(ANC) and nearly 50% of those with walled-off necrosis (WON) eventually require 
intervention [6,7]. 
The management of PFC and WON had a paradigm shift over the last three decades. Open 
necrosectomy was considered standard of care [8] until 1991 when Bradley and Allen 
demonstrated that conservative management is associated with better outcomes compared to 
surgical intervention in patients with acute sterile necrotising pancreatitis in the absence of 
infection [9].Historically, open surgical necrosectomy was the standard approach for managing 
infected necrotising pancreatitis and symptomatic sterile peripancreatic fluid collections 
(PFCs). However, this approach is associated with substantial perioperative stress, collateral 
tissue injury, and long-term complications, including pancreatico-cutaneous fistulas, exocrine 
and endocrine insufficiency, and incisional hernias[10-12]. 
Subsequently, the step-up approach beginning with percutaneous drainage followed by video-
assisted retroperitoneal debridement when necessary—emerged as the preferred management 
strategy, as established by the landmark PANTER trial [13]. 
Simultaneously there was emergence of endoscopic particularly endoscopic ultrasound (EUS) 
guided procedures. Multiple series from centres across Europe and the United States have 

validated the efficacy of endoscopic transluminal necrosectomy [14,15]. Furthermore, a pilot 
multicentre randomized controlled trial involving 22 patients suggested that endoscopic 
transluminal necrosectomy may offer advantages over surgical necrosectomy, particularly with 
respect to reducing the risk of new-onset multiple organ failure and overall complication 
rates[16]. 
Subsequently, EUS-guided drainage and necrosectomy have been widely adopted as the 
standard and first line treatment for WON in most patients [17]. 
Nutritional support is important in management of severe acute and necrotizing pancreatitis.  
Multiple randomized controlled trials and meta-analyses have demonstrated that enteral 
nutrition is superior to parenteral nutrition in reducing infections, surgical intervention rates, 
and mortality in patients with acute pancreatitis[18,19].These infections are thought to be 
mediated by bacterial translocation from the gut due to disturbed bacterial overgrowth and 
increased mucosal permeability. However, the timings to initiate enteral feeding is not clear.  
Nonrandomized studies in acute pancreatitis have shown that initiating naso-enteric tube 
feeding within 48 hours of admission, as opposed to later initiation, is associated with a 
significant reduction in major infectious complications and, in some studies, a decrease in 
mortality [20-22].Based on these studies the European guidelines recommend early initiation 
of enteral feeding within 24-72 hours[23]. 
However, there are no studies to guide the feeding strategies in patients with pancreatic fluid 
collections undergoing endoscopic transluminal drainage with LAMS and Endoscopic 
necrosectomy. 
Hence, we have designed an RCT to suggest feeding strategies in patients undergoing EUS-
guided cystogastrostomy (EUS-CG) in WON. 
 
Review of Literature 
Gut dysfunction in Acute pancreatitis (AP) 
The gastrointestinal tract has traditionally been viewed as an innocent bystander in critical 
illness, sustaining collateral damage. Reflex splanchnic vasoconstriction, aimed at preserving 
perfusion of vital organs, leads to ischemic injury, while subsequent resuscitation may 
exacerbate damage through reperfusion injury[24].One of the key pathological events 
following intestinal injury is the disruption of the epithelial barrier, leading to increased 
permeability. This breakdown permits the translocation of luminal bacteria and endotoxins into 
the portal venous system and mesenteric lymphatics, potentially triggering systemic 
inflammatory responses[25]. Gut barrier dysfunction in acute pancreatitis facilitates bacterial 

translocation from the intestinal lumen into the systemic circulation, thereby playing a critical 
role in the development of secondary infections. This microbial translocation contributes to 
systemic inflammatory responses, increasing the risk of sepsis, multiorgan failure, and 
ultimately, mortality[26]. Studies have shown that the microorganisms implicated in sepsis and 
pancreatic infections in acute pancreatitis are predominantly of enteric origin [24,27]. On index 
endoscopy, the most commonly identified organisms were Enterococci (45%), followed by 
Enterobacteriaceae (42%) and fungi (22%) [28,29]. 
 
Nutrition in acute pancreatitis (AP) 
Nutritional management in AP is an important aspect in treatment of AP.  
1. Malnutrition in AP and its impact on outcome 
Patients with acute pancreatitis are in hypercatabolic state and are at nutritionally high 
risk especially those with moderately severe or severe disease. The persistent acute 
inflammatory response leads to enhanced protein catabolism, third-space fluid shifts, 
and increased oxygen extraction from the bloodstream, thereby compromising the 
perfusion of vital organs. Additionally, impaired gut barrier function or infected 
pancreatic necrosis—resulting from enzymatic leakage—may further progress to 
sepsis[23]. One study showed that malnutrition in acute pancreatitis is associated with 
higher rates of death, sepsis, severe sepsis, septic shock, and respiratory failure [46]. 
Moreover, poor nutritional status is linked to adverse post-discharge outcomes, 
including increased dependence in activities of daily living, greater likelihood of 
requiring nursing home care, and higher mortality within one year following hospital 
discharge [47]. 
 
2. Enteral feed versus TPN: 
Enteral nutrition helps maintain gut mucosal integrity, promotes intestinal motility, 
prevents bacterial overgrowth, and enhances splanchnic blood flow [30]. Multiple 
randomized controlled trials, systematic reviews, and meta-analyses have consistently 
shown that enteral nutrition is safe and well-tolerated in patients with severe acute 
pancreatitis, leading to significant improvements in clinical outcomes such as reduced 
infectious and gastrointestinal complications, lower risk of tracheal aspiration, less pain 
exacerbation, earlier achievement of energy balance, decreased need for surgery, 
shorter hospital stays, reduced incidence of multi-organ failure, and lower mortality 
[31]. A recent meta-analysis by Wu et al., including 11 randomized controlled trials 

and 562 patients with severe acute pancreatitis, compared the efficacy of enteral 
nutrition (EN) versus parenteral nutrition (PN). The study demonstrated that EN 
significantly reduced the relative risk of mortality (RR = 0.43; P = 0.006), infections 
and complications (RR = 0.53; P< 0.001), and was associated with a lower need for 
surgical intervention and a shorter duration of hospitalization compared to PN. No 
significant difference in the incidence of multiple organ failure (MOF) was observed 
between the EN and PN groups (RR = 0.63; P = 0.059) [32]. Enteral nutrition may  
prevent infection of pancreatic necrosis in patients with severe acute pancreatitis 
[33,34]. A Cochrane meta-analysis of eight randomized controlled trials concluded that, 
compared to parenteral nutrition, enteral nutrition significantly reduced mortality, 
systemic infections, and the incidence of multiorgan failure in patients with acute 
pancreatitis [19]. However, several randomized trials have linked total parenteral 
nutrition (TPN) with an increased risk of infections and other complications. Therefore, 
PN should be used cautiously and only when enteral nutrition is not feasible, not 
tolerated, or insufficient to meet caloric needs [35]. 
 
3. Limitations of oral feeding in ANP and WON patients: 
Oral feeding intolerance (OFI) is a well-recognized clinical complication in the management 
of acute pancreatitis (AP). It is defined by the recurrence of gastrointestinal symptoms—
including abdominal pain, nausea, and vomiting on reintroduction of oral nutrition. OFI is 
frequently associated with biochemical derangements and increased analgesic requirements 
during hospitalization. Several previous studies have demonstrated that patients with oral 
feeding intolerance (OFI) experience a significantly prolonged length of hospitalization 
(LOH), with hospital stays averaging 5 to 35 days longer compared to those without OFI [36]. 
An international prospective cohort study conducted to evaluate the incidence, clinical 
predictors, and outcomes of oral feeding intolerance (OFI) in patients with acute pancreatitis 
(AP) reported that OFI developed in 13% of the study population [37]. Bevan et al. reported 
an overall incidence of OFI at 16% in a meta‐analysis including centres from multiple 
continents [36].  
The same meta-analysis identified the risk factors for OFI which includes peripancreatic fluid 
collection (PFC). The patient with peripancreatic fluid collection are at risk of OFI 3.5 times 
more than those without them. These symptoms may be attributed to the mass effect of the 
fluid collection, which can exert compressive pressure on the stomach, duodenum, and 

jejunum, leading to early satiety, vomiting, abdominal pain, and bloating. Other risk factors 
are pleural effusion and higher Balthazar and Ransom score [36].  
 
    
4. How to improve enteral nutrition role of NJ feeds  
Three randomized controlled trials comparing nasojejunal and nasogastric feeding routes 
in patients with severe acute pancreatitis found no significant differences in terms of 
feeding tolerance, complication rates, or mortality [38-40]. Four meta-analyses [41–44] 
have concluded that nasogastric tube feeding is a feasible, safe, and well-tolerated approach 
in patients with severe acute pancreatitis. Compared to nasojejunal feeding, it does not lead 
to higher rates of complications, mortality, recurrence of refeeding pain, or extended 
hospital stay. Unfortunately, to date, there have been no published studies specifically 
addressing the topic of nutritional support in patients with pancreatic collections treated 
using minimally invasive approaches. In a large Dutch trial demonstrating the superiority 
of the endoscopic approach over the surgical step-up strategy [84], specific data on 
nutritional support were not reported. However, all patients were provided with oral 
nutrition when tolerated. In cases of oral intolerance, enteral nutrition was delivered via a 
nasojejunal feeding tube, and parenteral nutrition was administered when enteral nutrition 
was contraindicated [45]. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Aims and Objectives: 
 
Aim:    
To compare outcomes of Nasojejunal feeding vs oral feeding following endoscopic 
transluminal drainage in patients with symptomatic walled-off necrosis  
 
Primary Objectives: 
1. To compare the rate of nutritional failure at Day 14 between Nasojejunal and oral 
feeding post endoscopic transmural drainage of WON.  
 
Secondary Objectives: 
1. To compare infection rates, need for antibiotic escalation and new onset organ 
failure 
2. To compare re-intervention needs and hospital stay duration 
3. To compare patient weight, serum albumin and inflammatory markers (CRP) 
4. To compare  GI complications (Vomiting, diarrhoea, aspiration pneumonia, feeding 
intolerance) 
5. To compare patient reported outcomes (appetite, pain ,quality of life) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Materials and Methods: 
Study design 
The study will be a prospective, open label, single centre, randomized controlled trial.  It will 
be conducted in the Department of Gastroenterology, PGIMER, from July 2025 to December 
2026 
Study Population:  
All patients presented to PGIMER with WON due to acute pancreatitis requiring EUS guided 
transluminal drainage will be screened for inclusion criteria.  
 
Inclusion criteria 
1. Patients of acute pancreatitis (AP) with 18-75 years of age  
2. Patients with symptomatic WON requiring EUS guided transluminal drainage  
3. Provision of written informed consent 
Exclusion criteria  
1. Patients with collection not amenable for EUS guided drainage (distance of WON >1 
cm from the gastrointestinal lumen) 
2. Known malignancy or immunocompromised state 
3. Previous upper gastrointestinal(GI) surgery interfering with absorption 
4. Active GI bleeding 
5. GI obstruction, ileus or persistent vomiting 
6. Patients moribund to undergo endoscopic procedure (Glasgow coma scale <8 or 
patients on ventilatory support) 
7. Patients with irreversible coagulopathy like platelets <50,000/mm3 and/or INR>1.5 
8. Pregnant or lactating female 
 
WON: WON will be defined as a mature, encapsulated collection of pancreatic and/or 
peripancreatic necrosis that has developed a well-defined inflammatory wall. [3] 
Symptomatic WON: It will be defined by any of the following: 1) Infected WON, or 2) 
Presence of pressure symptoms like abdominal pain, early satiety, weight loss or biliary duct 
compression or 3) persistent pain abdomen 

Infected WON: It will be defined by any of the following: 1) As evident on by a positive 
Gram’s stain or culture from a fine-needle aspiration or 2) the presence of gas configurations 
within collection on contrast-enhanced computed tomography (CT) or 3) clinical signs of 
infection; defined as persistent organ failure or persistence of two inflammatory variables 
(temperature >38.5°C or elevated C-reactive protein levels or leukocyte counts) during 3 
consecutive days. 
SIRS: Presence of ≥ 2 out of the following parameters: Temperature < 36C or >38C, Total 
leukocyte count < 4000/mm3or >12000/mm3, Respiratory rate > 20/min or PaCO2 of < 
32mmHg, Heart rate > 90/minute [41] 
Organ failure- It will be defined as per modified Marshall criteria [4] 
Technical success: Successful placement of metal stent with EUS guided transluminal 
drainage. 
Clinical success: Post endoscopic treatment collection size ≤ 3 cm on any cross-sectional 
imaging before removal of metal stent along with resolution of initial symptoms requiring 
drainage.  
 
Randomization: Patients needing EUS guided drainage with LAMS for symptomatic WON 
will be randomized once they fulfil inclusion criteria. Computer generated randomization 
assignments will be provided in advance using block randomisation and placed in sequentially 
numbered sealed envelopes. They will be opened during the procedure to determine treatment 
allocation.  
Study flow:  
Patients of AP with infected WON who are planned for EUS guided transluminal drainage by 
LAMS will be screened for inclusion criteria. Patients who fulfilled inclusion criteria will be 
randomized into either Nasojejunal (NJ) feeding or oral feeding after informed consent.  
 
Sample size:  
Since it is a pilot study and in a year the unit treats approximately 80-100 patients with WON 
and therefore considering exclusions a feasibility sample size of 20 in each arm will be taken.  
 
Techniques:  
Initial diagnostic EUS: 
EUS examination will be done under conscious sedation using intravenous midazolam. Linear 
scanning echoendoscope (EG-3870 UTK linear echoendoscope, Pentax Inc., Tokyo, Japan or  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                                                 
 
 
ALLOCATION 
 
 
 
 
 
FOLLOW 
UP 
 
 
 
 
 
 
 
 
Patients with WON due to acute pancreatitis 
presenting to PGIMER will be screened 
EE 
ENROLMENT 
EXCLUDED 
1. 
Patients with collection not 
amenable for EUS guided 
drainage (distance of WON 
>1 cm from the 
gastrointestinal lumen) 
2. 
Known malignancy or 
immunocompromised state 
3. 
Previous upper 
gastrointestinal(GI) surgery 
interfering with absorpti 
4. 
Active GI bleeding 
5. 
GI obstruction, ileus or 
persistent vomiting 
6. 
Patients moribund to 
undergo endoscopic 
procedure (Glasgow coma 
scale <8 or patients on 
ventilatory support) 
7. 
Patients with irreversible 
coagulopathy like platelets 
<50,000/mm3 and/or 
INR>1.5 
8. 
Pregnant or lactating female 
Inclusion Criteria 
1. acute pancreatitis (AP) with 18-75 years 
of age 
2. symptomatic WON needing EUS 
guided transluminal drainage 
3. rovision of informed written consent 
 
 
Randomization 
(
40)
Group A (n=20) 
Nasojejunal 
feeding 
Group B: 
(n=20) 
Oral feeding 
Follow up (n=20) 
Nutritional failure at 
Day 14 
Analysis 
(n=20) 
ANALYSIS 
Follow up (n=20) 
Nutritional failure at 
Day 14 
Analysis 
(n=20) 

UCT180 linear echoendoscope, Olympus Optical Co Ltd, Tokyo, Japan) will be used at a 
frequency of 7.5 MHz. The WON and surrounding areas will be first carefully scanned on EUS 
with special emphasis on size as well as detailed morphology of WON. Colour Doppler will 
be used to detect any intervening vascular collaterals. 
Quantification of solid necrotic debris on EUS: 
The echogenic material present in the WON is suggestive of solid necrotic debris. An attempt 
to quantify the amount of solid debris as percentage of total size of collection will be done. The 
quantification of the solid debris will be an approximate visual judgment of the endoscopist.  
 
 

Randomization: 
A. Nasojejunal (NJ) feeding group:  
• Patients randomized to this group will have NJ placement within 24 hours post-
drainage.  
• NJ will be placed endoscopically 
• NJ position will be confirmed by Abdominal X-ray (AXR) 
• Standard formula feed will be initiated immediately after placing and 
confirming the NJ position with a rate of 
o  First 24 hours :                                         25 ml/hr 
o Between 24-48 hours :                              50 ml/hr 
o Between 48-72 hours:            increase to full nutrition 
o After 72 hours:                       Full nutrition 
• Full nutrition is defined as an energy target of 30kcal/kg/day 
.  
B. Oral feeding group:  
• Patients randomized to this group will initiated on oral feed post procedure as 
tolerated.  
• Patient will be started on oral liquid then on soft diet. Escalation will be guided 
based on feed tolerance. Oral diet will be supplemented with parenteral nutrition 
if caloric intake is <60% of target calorie at Day 5. 
 
Nutritional failure at Day 14: 
Definition:  
• <75% calorie requirements are met 
• Need for parenteral nutrition 
• Severe GI intolerance requiring feed modification 
Infectious complications: 
The patient should have signs of bacterial infections/fungal infections i.e. body temperature 
>1000 F and raised leukocytes, CRP, Procalcitonin, beta-D glucan and galactomannan. 
 
 
 
 

Infection 
Definition 
Infected pancreatic necrosis Positive culture after first percutaneous drainage procedure of 
collection with (peri-) pancreatic necrosis  
Bacteremia 
Positive blood culture Positive culture in 1 blood culture. In case of 
coagulase negative 
staphylococci or other non-virulent micro-organisms at least 2 blood 
culture bottles are mandatory. 
 
Pneumonia 
Coughing, dyspnoea, radiography with infiltrative abnormalities and 
positive culture in sputum. On the intensive care unit, a positive 
endotracheal culture is mandatory 
Sepsis 
SIRS and positive blood culture 
 
 
 
 
Statistical analysis: 
All patients after randomization will be evaluated for primary and secondary endpoints. Data 
will be explored for any outliers, errors and missing values. When data will be normally 
distributed, continuous variables will be compared using Student’s t-test. For skewed data, 
Mann-whitney test will be used. Quantitative data will be described as median with range and 
mean with standard deviation. Categorial data will be shown as proportions. Multiple linear 
regression analysis will be performed to identify risk factors for requirement of additional 
intervention after initial drainage procedure. 95% confidence interval will be taken as a cut-off 
for significance. Intention to treat and per-protocol analysis will be performed. The analysis 
was performed using Statistical Packages for the Social Sciences (SPSS Inc, Chicago, IL, 
version 22.0 for windows).  
 
 
 
 
 

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JPEN 
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Enteral 
Nutr. 
2016;40:487–497. 
doi: 
10.1177/0148607114567902. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Thesis Proforma 
Name:  
 
                       Age (years):   
 
   Gender: (M/F) 
CR No:                                                      Admission No:                                          Phone 
number: 
Date of Pain:  
 
          Date of admission: 
 
    Date 
of 
Discharge/Death: 
Etiology:  
 
 
           Severity:                                                  BMI: 
Details Organ Failure:  
Type of Organ failure 
Date of Onset 
Date of resolution 
Maximum 
organ 
support 
Acute lung injury 
 
 
 
Acute kidney injury 
 
 
 
CVS Failure 
 
 
 
 
Baseline reports at inclusion: 
Date 
 
 
 
Hemoglobin 
 
S.Ca/Po4 
 
TLC 
 
Fasting TG 
 
Platelets 
 
TC/LDL/HDL 
 
Urea/Creatinine 
 
IgA tTG 
 
TB/DB 
 
iPTH 
 
AST/ALT/ALP 
 
HbA1c 
 
TP/Albumin 
 
CRP 
 
APACHE II 
 
Stool R/M 
 
BISAP Score 
 
Vitamin D3 
 
 
Date 
 
 
 
 
Procalcitonin 
 
 
 
 
Beta-D Glucan 
 
 
 
 
Galactomannan  
 
 
 
 
 
 
 

Baseline Nutritional assessment: 
Date 
 
Weight 
 
Height 
 
BMI 
 
Calorie intake /day 
 
Protein intake/day 
 
Current route of nutrition 
 
 
 
Imaging:  
 
Index 
imaging 
(before 
procedure) 
Index 
Imaging 
(After 
procedure) 
 
USG/CT/MRI: 
 
 
Date/ PGI No. 
 
 
Collections:  
PN/EPN/PN+EPN 
 
 
Location of collection:  
 
 
Size of collection: 
 
 
Extension: 
 
 
Gas 
configuration 
within 
collection: 
 
 
Vascular complications: 
 
 
Pleural effusion/ ascites: 
 
 
CTSI/ modified CTSI 
 
 
Clinical success (Y/N) 
 
 
 
 
Follow up Imaging: 
 
 
1 
2 
3 
4 
CT/MRI 
 
 
 
 

Date/ PGI No. 
 
 
 
 
Collections:  
PN/EPN/PN+EPN 
 
 
 
 
Location 
of 
collection: 
 
 
 
 
Size of collection:  
 
 
 
Extension: 
 
 
 
 
Gas 
configuration 
within collection 
 
 
 
 
Vascular 
complications: 
 
 
 
 
Pleural effusion/ 
ascites: 
 
 
 
 
Clinical 
success 
(Y/N) 
 
 
 
 
 
 
Indication of Drainage:  
1. Positive gram stain/culture 
2. Gas configuration within collection 
3. Clinically suspected infection 
4. Compressive symptoms (gastric outlet obstruction or biliary obstruction) 
5. Pressure symptoms (early satiety, weight loss) 
6. Persistent pain abdomen 
 
Disease characteristics at time of drainage: 
Days from onset of acute pancreatitis: 
Days from hospitalization: 
Ongoing Fever: (Y/N); Days:  

Ongoing SIRS: 1/2/3/4: Days: 
Ongoing OF: (Y/N); Type of organ failure (ALI/AKI/CVSF); Days of ongoing OF:  
 
Index drainage by EUS:  
Date  
 
Size of collection 
 
Percentage of necrosis 
 
Stent used  
 
Any Periprocedural complications 
 
 
Randomization:  
A. Oral feed: 
Nutritional assessment: 
Date 
Day 0 
Day 1 
Day 2 
Day 5 
Day 8 
Day 11 
Day 14 
Calorie 
intake 
 
 
 
 
 
 
 
Protein 
intake 
 
 
 
 
 
 
 
Change 
in route 
 
 
 
 
 
 
 
 
Weight 
Day 0 
Day 14 
 
 
 
 
Date 
Day 0 
Day 7 
Day 14 
Albumin 
 
 
 
CRP 
 
 
 
Total 
length 
of 
hospitalization 
 
 
 
 
 
 

Date 
Adverse events related to feed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date 
Indication 
NCD 
used 
Stent 
migration/
Blockage 
Stent 
removal/  
PS 
placement 
Complete 
necrosectomy 
Complication 
DEN 1 
 
 
 
 
 
 
DEN 2 
 
 
 
 
 
 
DEN 3 
 
 
 
 
 
 
 
 
 
B. Metal Stent NJ feed: 
Nutritional assessment: 
Date 
Day 0 
Day 1 
Day 2 
Day 5 
Day 8 
Day 11 
Day 14 
Calorie 
intake 
 
 
 
 
 
 
 
Protein 
intake 
 
 
 
 
 
 
 
Change 
in route 
 
 
 
 
 
 
 
 
 

Weight 
Day 0 
Day 14 
 
 
 
 
Date 
Day 0 
Day 7 
Day 14 
Albumin 
 
 
 
CRP 
 
 
 
Total 
length 
of 
hospitalization 
 
 
 
 
Date 
Adverse events related to feed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date 
Indication 
Stent 
migration/
Blockage 
Stent removal/  
PS placement 
Complete 
necrosectomy 
Complication 
DEN 1 
 
 
 
 
 
DEN 2 
 
 
 
 
 
DEN 3 
 
 
 
 
 
 
 
 
 
 

Parameters after Index Procedure: 
 
Day 0 
Day 3 
Day 7 
Day 14 
Day 21 
Day 28 
Fever 
 
 
 
 
 
 
SIRS 
 
 
 
 
 
 
OF 
ALI 
 
 
 
 
 
 
AKI 
CVSF 
Hemoglobin 
 
 
 
 
 
 
TLC 
 
 
 
 
 
 
CRP 
 
 
 
 
 
 
APACHE II 
 
 
 
 
 
 
BISAP 
 
 
 
 
 
 
Urea/Crt 
 
 
 
 
 
 
T. Bil/ D. Bil 
 
 
 
 
 
 
Albumin 
 
 
 
 
 
 
AST/ALT/ALP 
 
 
 
 
 
 
Procalcitonin 
 
 
 
 
 
 
Blood Culture 
 
 
 
 
 
 
NCD culture 
 
 
 
 
 
 
PCD culture 
 
 
 
 
 
 
 
Fluid Analysis: 
 
Total 
cells/ 
Differential 
cells 
Glucose 
Protein/ 
Albumin 
Amylase/ 
Lipase 
LDH 
CA 19.9 
Culture 
Ascitic 
fluid 
 
 
 
 
 
 
 
NCD / 
WON 
fluid 
 
 
 
 
 
 
 
PCD 
fluid 
 
 
 
 
 
 
 
 
Antibiotics: 

No 
Antibiotics/ 
Antifungal 
Culture 
based 
(Y/N) 
Duration No 
Antibiotics/ 
Antifungal 
Culture based 
(Y/N) 
Duration 
1 
 
 
4 
 
 
 
2 
 
 
5 
 
 
 
3 
 
 
6 
 
 
 
 
Requirement of Percutaneous drainage catheter: (Y/N) 
Indication:  
 
 
 
Site:   
 
Size:   
 
 
Duration:  
 
 
 
Requirement of surgical intervention: (Y/N) 
Indication:  
 
 
 
Site:   
 
Size:   
 
 
Duration:  
 
 
 
Complications during any intervention:  
 
 
 
 
Technical success: (Y/N) 
Clinical success: (Y/N) 
Time duration at clinical success: (Y/N) 
Metal stent exchanged with plastic stent: (Y/N)